Senior Manager, Medical/Regulatory Writer Immunocore Holdings PlcSenior Manager, Medical/Regulatory WriterRadnor, PAVacancy NameSenior Manager, Medical/Regulatory Writer Vacancy NoVN831 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA, Remote, US DepartmentRegulatory Affairs Key ResponsibilitiesThe Senior Manager, Medical/Regulatory Writer will be accountable for leading and overseeing the medical and scientific regulatory writing for assigned programs to support submissions from first-in-human studies through product registration. Authoring or supervising the preparation of other regulatory documents required for Health Authority submissions, including but not limited to: Clinical Summaries (Clinical Overview, ISS/ISE, PK/PD summary, Advisory Committee Briefing document), Investigator Brochure(s), DSURs, other regulatory documents including briefing documents for health authorities, responses to Health Authority questions, etc.
Senior Project Manager - Quality & Regulatory Transformation Zp Group LlcSenior Project Manager - Quality & Regulatory TransformationHorsham, PAThis opportunity is ideal for a senior project management professional who excels in complex, highly regulated environments and has a proven track record of delivering transformational initiatives while navigating regulatory and business-critical priorities. This individual will oversee complex, cross-functional workstreams while partnering with Quality, Regulatory Affairs, IT, and business stakeholders to drive successful execution of high-priority deliverables.
Global Regulatory CMC Manager TechDigital CorporationGlobal Regulatory CMC ManagerTrenton, NJ2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Skills/Knowledge Required: ¿ Experience with CMC regulatory documents (IND/CTAs, BLAs, MAAs, responses and variations).
Regulatory Operations Manager Actalent IncRegulatory Operations ManagerHarleysville, PA$105,000–$115,000 / yearThe position also manages regulatory and compliance support for customers, collaborates closely with internal stakeholders to maintain and improve the quality system, and proactively monitors the regulatory landscape to identify and address compliance risks. Establish and maintain a comprehensive regulatory operations program that supports cosmetics under MoCRA, OTC pharmaceutical products, medical devices, and other regulated product categories in all markets served.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerPhiladelphia, PA$144,600–$265,100 / yearCandidates joining our firm should possess an entrepreneurial drive, intellectual curiosity, creativity, and critical thinking in addition to the qualifications below: Strong oral and written communication skills, including the ability to support or lead business proposal development and sales presentations. As a Manager, you will have opportunities to: Oversee and direct end-to-end client projects focused on digital asset risk, regulatory compliance, and licensing, owning project scoping, resource allocation, timelines, quality, and deliverables.
Senior Regulatory Project Manager ICON PlcSenior Regulatory Project ManagerBlue Bell, PAWhat You Will Do: The Regulatory Project Manager collaborates with regional and global cross functional teams to plan, prepare and deliver compliant regulatory submissions, providing support to ensure all business deliverables are met. Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client's needs and regulatory team goals.
Ambulatory Regulatory & Accreditation Program Manager - Jefferson Health Systems Thomas Jefferson UniversityAmbulatory Regulatory & Accreditation Program Manager - Jefferson Health SystemsPhiladelphia, PennsylvaniaJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University , home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
Audit Manager II (US) - Financial Crimes - Regulatory Issue Validation The Toronto-Dominion BankAudit Manager II (US) - Financial Crimes - Regulatory Issue ValidationMount Laurel, NJ$92,220–$149,310 / yearThe main function of the Audit Manager II - U.S. Financial Crimes Regulatory Issue Validation Audit is to oversee testing of design and operational effectiveness focused on Regulatory Issue validation as well as Internal issue validation tied to regulatory issues and managing the suite of work required to meet regulatory deadlines and internal timelines through tracking and monitoring all items within the teams scope of work. Job Description: The Audit Manager II is a senior-level leader within the U.S. Financial Crimes Regulatory Issue Validation Audit function, providing specialized in-depth subject matter expertise and responsible for Validating Regulatory Issues working through the audit methodology and working directly with impacted businesses and contributing to the planning and oversight to the validation function.
Senior Specialized Finance Manager (US) - Regulatory Policy and Review The Toronto-Dominion BankSenior Specialized Finance Manager (US) - Regulatory Policy and ReviewMount Laurel, NJ$115,400–$173,160 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Customer Accountabilities: Focuses on comprehensive reviews, specialized analysis, audits and/or initiatives and a variety of complex projects and initiatives requiring seasoned specialist knowledge and/or the integration of cross functional processes within own area of expertise.
Regulatory Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerPhiladelphia, PA$82,600–$162,800 / yearManage end to end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring compliance with applicable regulatory requirements across various regulators such as SEC, CFTC, BEA, NFA, Treasury. We "embed continuous advantage" through domain, industry, technology and transformation skills to perform client business functions that manage risk and deliver value-added outcomes, all while driving predictable long-term revenue, profitability, and growth.
NewAudit Manager II (US) - Financial Crimes - Regulatory Issue Validation TD BankAudit Manager II (US) - Financial Crimes - Regulatory Issue ValidationMount Laurel, New YorkThe main function of the Audit Manager II – U.S. Financial Crimes Regulatory Issue Validation Audit is to oversee testing of design and operational effectiveness focused on Regulatory Issue validation as well as Internal issue validation tied to regulatory issues and managing the suite of work required to meet regulatory deadlines and internal timelines through tracking and monitoring all items within the teams scope of work. The Audit Manager II is a senior-level leader within the U.S. Financial Crimes Regulatory Issue Validation Audit function, providing specialized in-depth subject matter expertise and responsible for Validating Regulatory Issues working through the audit methodology and working directly with impacted businesses and contributing to the planning and oversight to the validation function.
1940 Act Regulatory Administration Manager U.S. Bancorp1940 Act Regulatory Administration ManagerPhiladelphia, PA$139,230–$163,800 / yearServes as a resource on regulations and industry developments for fund customers in support of legal counsel and as a resource for internal related business lines with regard to matters concerning regulation of investment companies and industry developments. In addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures.
New1940 Act Regulatory Administration Manager US Bank1940 Act Regulatory Administration ManagerPhiladelphia, PA$139,230–$163,800 / yearServes as a resource on regulations and industry developments for fund customers in support of legal counsel and as a resource for internal related business lines with regard to matters concerning regulation of investment companies and industry developments. In addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures.
Ent Amb Regulatory Prog Mgr Thomas Jefferson UniversityEnt Amb Regulatory Prog MgrPhiladelphia, PAJefferson is more than 65,000 people strong, dedicated to providing the highest-quality, compassionate clinical care for patients; making our communities healthier and stronger; preparing tomorrow's professional leaders for 21st-century careers; and creating new knowledge through basic/programmatic, clinical and applied research. Thomas Jefferson University, home of Sidney Kimmel Medical College, Jefferson College of Nursing, and the Kanbar College of Design, Engineering and Commerce, dates back to 1824 and today comprises 10 colleges and three schools offering 200+ undergraduate and graduate programs to more than 8,300 students.
NewSr. Manager, Information Security - U.S. Regulatory Remediation Assurance Lead The Toronto-Dominion BankSr. Manager, Information Security - U.S. Regulatory Remediation Assurance LeadMount Laurel, NJ$123,680–$200,200 / yearJob Description: The Senior Manager Information Security manages / leads a team of Technology Controls / Information Security experts in the development and/ or management of relevant strategies, programs, tools, frameworks and policies and provides specialized oversight / control / governance activities for a key business line/segment or transformational (change the bank) strategic initiative / program, liaising across the organization and primarily interfacing with executive and/or functional stakeholders to minimize overall technology risks to the Bank for own area. Oversees the expanding U.S. CISO 1B Assurance Testing program, which is expected to expand to include and challenge of Critical and High-rated Internal Audit findings and Self-Identified (Self-ID) issues (in addition to regulatory remediation activities), applying a consistent risk-based assurance methodology to validate remediation design, implementation, effectiveness, and sustainability.
Financial & Regulatory Reporting Associate Manager U.S. BancorpFinancial & Regulatory Reporting Associate ManagerHorsham, PA$92,820–$109,200 / yearIn addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures. Reviews the accounting and financial statement information provided for audit and tax reviews, documentation and set-up of the accounting principles for unusual investment types, and set-up/processing of complex expense and incentive fee calculations and reconciliation items.
NewFinancial & Regulatory Reporting Associate Manager U.S. BankFinancial & Regulatory Reporting Associate ManagerPhiladelphia, PennsylvaniaIn addition, certain positions may also be subject to the requirements of FINRA, NMLS registration, Reg Z, Reg G, OFAC, the NFA, the FCPA, the Bank Secrecy Act, the SAFE Act, and/or federal guidelines applicable to an agreement, such as those related to ethics, safety, or operational procedures. Reviews the accounting and financial statement information provided for audit and tax reviews, documentation and set-up of the accounting principles for unusual investment types, and set-up/processing of complex expense and incentive fee calculations and reconciliation items.
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesNorth Wales, PA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Senior Director, Regulatory Affairs ICON PlcSenior Director, Regulatory AffairsBlue Bell, PAAs a Senior Director, Regulatory Affairs at ICON, you will provide strategic direction and management of Regulatory Affairs teams (up to 80 team members) and projects and contribute to the strategic direction and overall management of the Regulatory Affairs function at ICON strategic solutions. Key responsibilities include: Lead and oversee the regulatory affairs strategy for ICON's therapeutic area teams as a departmental leader, set a clear and convincing future direction, while communicating with clarity.
["Regulatory Affairs Assistant","Regulatory Affairs Assistant"] Apex Systems["Regulatory Affairs Assistant","Regulatory Affairs Assistant"]ConshohockenIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorPennington, NJ$94,556.80–$124,176 / yearSUMMARY: Reporting to the Manager of Regulatory Affairs, coordinates organization-wide as well as program-specific activities related to the regulatory process and the respective governing bodies, including NJ Department of Health, Centers for Medicare and Medicaid Services (CMS), DNV and others. When determining base salary and/or rate, several factors may be considered including, but not limited to location, years of relevant experience, education, credentials, negotiated contracts, budget, market data, and internal equity.
NewSenior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy InsmedorporatedSenior Director, Regulatory Affairs, Global Regulatory Lead - Development StrategyNew JerseyRemoteYou will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress.
Associate Director, Commercial Regulatory Affairs Bristol-Myers Squibb CoAssociate Director, Commercial Regulatory AffairsPrinceton, NJ$173,350–$210,058 / yearResponsibilities include: Provides regulatory advice, risk assessment and mitigation strategies to Commercial Teams, Medical Affairs, Public Affairs, Value Access and Payment, and other internal groups, on all promotional materials, including concepts, disease awareness, and institutional campaigns on assigned product/therapeutic area. Description: The role of Associate Director of US Commercial Regulatory Affairs requires the ability to apply complex scientific and expert regulatory advice and risk assessment for the development of promotional campaigns and materials for an assigned product/therapeutic area in order to help ensure the Company's objectives are met.
Senior Director, Regulatory Affairs (Ad Promo) Bausch Health Companies IncSenior Director, Regulatory Affairs (Ad Promo)Philadelphia, PA$215,000–$296,000 / yearRepresents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo. Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA.
Vice President, Global Regulatory Affairs, Team Lead, Strategy Genmab ASVice President, Global Regulatory Affairs, Team Lead, StrategyPrinceton, NJFor 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. The Vice President, Global Regulatory Affairs Strategy is a key leadership role within Global Regulatory Affairs, responsible for managing the regulatory strategy and regulatory deliverables for a portfolio of assets across all stages of development.
Regulatory Affairs Specialist, Global Quaker HoughtonRegulatory Affairs Specialist, GlobalConshohocken, PASupport chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system. Supports the Product Stewardship organization globally with responses to key stakeholders including regulatory inquiries, SDS authoring, and answering regulatory inquiries.
Director of Regulatory Affairs,Tactical and Implementation Immunocore Holdings PlcDirector of Regulatory Affairs,Tactical and ImplementationRadnor, PA$157,500–$262,500 / yearExperience & knowledge Essential: • Solid track record in drug development and leadership within a dynamic project team • Emerging understanding of global regulatory requirements to be able to formulate tactical regulatory strategies • Ability to prepare and submit regulatory documentation to ensure regulatory compliance globally • Emerging ability to propose scientific regulatory strategies that are reviewed with line management for concurrence and approval • Excellent knowledge of US regulatory requirements and experience with submissions gained within drug development. The individual will also be assigned projects and regulatory activities by providing expertise to Immunocores development programs to include regulatory implementation of regulatory strategies, IND developments, submission, maintenance, tracking BLAs, BLA planning, submission, maintenance, tracking agency liaison for specific tactical assignments and regulatory intelligence for tactical process-related changes in requirements.
Prin. Scientist, Regulatory Liaison Merck & Co IncPrin. Scientist, Regulatory LiaisonNorth Wales, PA$173,200–$272,600 / yearPrimary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.
Regulatory Affairs ManagerTitusville NJ/ Raritan NJ/ Springhouse PA Integrated Resources, IncRegulatory Affairs ManagerTitusville NJ/ Raritan NJ/ Springhouse PAHopewell Township, New JerseyContractorProvides cross-functional leadership to the submission teams in executing the finalized pre-submission plan, including direct management of Modules 1 and 2.Proactively plans and manages the cross-functional project deliverables that support the global regulatory strategy and worldwide submissions (NA – EMEA - APJLA): Active follow-up on the progression of all regulatory activities required to successfully and timely complete the regulatory deliverables (Health Authorities interactions, submissions. ) Monitors regulatory driven key milestones, decision points and critical path activitiesCreates project related reports to support decision making at PMT, GRT and CDT level, supports regulatory portfolio oversight, supports team member planning of short and long term deliverables; informs stakeholders on project deliverables status.
Associate Director, Regulatory Affairs Project Planning & Coordination ACADIA Pharmaceuticals Inc.Associate Director, Regulatory Affairs Project Planning & CoordinationPrinceton, NJ$154,000–$193,000 / yearWe are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. The Associate Director, Regulatory Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals.
EG-140 - Regulatory Affairs / Medical Writing Bristol-Myers Squibb CoEG-140 - Regulatory Affairs / Medical WritingPrinceton, NJ$170,880–$207,061 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Demonstrated expert writing skills in authoring and managing the production of clinical and regulatory document including registrational submission documents (eg, briefing documents, CTD summary documents, responses, pediatric plans).
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineUpper Gwynedd, PA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Regulatory Affairs Assistant StratAcuity Staffing Partners IncRegulatory Affairs AssistantConshohocken, PA$25–$30 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Support chemical regulatory activities related to documentation including updating raw material information, communicating changes to raw material classifications, data management and updating the SDS system.
Director, Regulatory Affairs Advertising & Promotion Acadia Pharmaceuticals IncDirector, Regulatory Affairs Advertising & PromotionPrinceton, NJ$193,400–$241,800 / yearThe position partners closely with cross-functional teams to support the timely approval and distribution of promotional and disease state materials, serves as the primary liaison with the FDA''s Office of Prescription Drug Promotion (OPDP) for advertising and promotional submissions, and contributes to labeling strategies for regulatory submissions across Acadia''s product portfolio. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.
Director, Global Regulatory Affairs Lead (Oncology) GSK plcDirector, Global Regulatory Affairs Lead (Oncology)Collegeville, PA$171,750–$286,250 / yearProven track record of facilitating groups of individuals to work together on creating solutions and developing regulatory strategies, proactively seeking information and insight from a broad range of sources and weight benefits and risks before making important decisions. Works with the respective GRS TG Portfolio Lead and TG VP to ensure a robust regulatory strategy and appropriate TG resource is in place to support respective development programs to meet the needs of the key markets identified in the IES and the Medicine Profile.
NewSenior Associate Regulatory and Business Continuity Sun Pharmaceutical Industries LtdSenior Associate Regulatory and Business ContinuityPrinceton, NJ$102,500–$125,000 / yearRenew the establishment registrations (ER) for the manufacturing and packaging sites and coordinate with other department in the company to ensure that the establishments and product fees (PDUFA program fee) are paid to the FDA before its deadline. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
Regulatory Program Coordinator Temple UniversityRegulatory Program CoordinatorPhiladelphia, Pennsylvania$50,000–$55,000The Regulatory Program Coordinator, under the supervision of the Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI's, and research clinical staff in the Lewis Katz School of Medicine's Thoracic Medicine & Surgery department. Temple University's Lewis Katz School of Medicine's Pulm/Critical Care/SleepMed Department is searching for a Regulatory Program Coordinator to join our team.
Sr. Principal Scientist (Sr. Director) - Regulatory Liaison Merck & Co IncSr. Principal Scientist (Sr. Director) - Regulatory LiaisonNorth Wales, PA$190,800–$300,300 / yearRequired Skills: Biological Sciences, Clinical Reporting, Drug Development, Global Health, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Pharmaceutical Regulatory Affairs, Process Improvements, Product Approvals, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Strategies, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Director, Regulatory Affairs, Ex-US Larimar Therapeutics IncDirector, Regulatory Affairs, Ex-USPAProvide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings • Develop internal regulatory procedures and practices • Work closely with RA Sr. Requirements: Key Experience, Skills and Knowledge: • Minimum of 4-year undergraduate degree • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred • Understanding of GxP systems and Quality principles • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications • Excellent communication, time management and project management skills • Continuous quality improvement mindset and attention to details • Can do attitude, flexibility, and mental agility.
Senior Director, Global Regulatory Lead Neuroscience Bristol Myers SquibbSenior Director, Global Regulatory Lead NeurosciencePrinceton, NJ$258,680–$313,460 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead on assigned development assets and marketed products: Develop global therapeutic regulatory strategies and operational plans for identified investigational and marketed products.
Sr Director and Team Lead, Regulatory Labelling Strategy and Development, Oncology GSK plcSr Director and Team Lead, Regulatory Labelling Strategy and Development, OncologyCollegeville, PA$221,925–$369,875 / yearItalian Salary Range / Fascia retributiva in Italia: EUR 123,000 to EUR 205,000Belgium Salary Range / Fourchette salariale - Belgique: EUR 141,750 to EUR 236,250The annual gross base salary range for new hires in this position is listed above for each applicable location. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success.
Regulatory Specialist Globus MedicalRegulatory SpecialistAudubon, PennsylvaniaThe Regulatory Affairs Specialist assists with drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. Minimum of 2-5 years’ experience in Regulatory Affairs in the medical device industry,, preferably within orthopedic medical devices; Experience in medical device development and registration of products.
Senior Regulatory Affairs Specialist Integrated Resources, IncSenior Regulatory Affairs SpecialistCranbury Township, New JerseyFull timeSenior Regulatory Affairs SpecialistA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. The position will also assist in labeling for new products, changes to labeling for existing prescription and OTC products.
Associate Director Regulatory Affairs, Oncology GSK plcAssociate Director Regulatory Affairs, OncologyCollegeville, PA$138,750–$231,250 / yearThis role will ensure the development of appropriate global and/or regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy /Integrated Asset plan to ensure the development program meets the needs of the key markets identified and the Medicines Profile. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile.
Associate Director Global Regulatory Sciences - Oncology Bristol-Myers Squibb CoAssociate Director Global Regulatory Sciences - OncologyPrinceton, NJ$199,350–$241,566 / yearBased on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Regulatory Associate Globus Medical, Inc.Regulatory AssociateAudubon, PAThe Regulatory Affairs Associate assists in drafting, submitting and gaining clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. + Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting.
Associate Director, Regulatory University of PennsylvaniaAssociate Director, RegulatoryPhiladelphia, PA$105,500–$130,000 / yearThe Associate Director for Regulatory Affairs will also serve as the key departmental stakeholder representing the department/division when working with internal regulatory groups including the University of Pennsylvania's Institutional Review Board (IRB), the Office of Clinical Research (OCR), and any other ancillary oversight groups; as well as for external entities including pharmaceutical companies, contract research organizations (CROs), the FDA, and research networks such as the National Cancer Institute Cooperative/Clinical Network Groups in the conduct of clinical trials. They will assist the Director with facilitating and tracking the flow of new research studies through the start-up process, by identifying regulatory obstacles to activation, and propose improvements to the process will track, analyze and report to senior leadership department-wide trial characteristics, accrual information and audit/monitoring findings; such reports will include an assessment of trial information, areas of potential risk or roadblocks to success, and potential corrective actions.
HR Business Partner - Global Regulatory GSK plcHR Business Partner - Global RegulatoryCollegeville, PABusiness Acumen, Cultural Change Management, Data Analysis, Digital Fluency, Leadership Training and Development, Organizational Development (OD), Risk Management, Stakeholder Management, Strategic Resource Planning, Talent Management. Reward and Retention Strategy: In partnership with Reward experts, apply business acumen and sound judgement within the context of GSK reward strategy to develop and deliver plans which enable the delivery of business priorities.
Vice President, Site Activation Project Management and Global Regulatory Oversight ICON PlcVice President, Site Activation Project Management and Global Regulatory OversightBlue Bell, PARemoteAs the Vice President, Site Activation Project Management and Global Regulatory Oversight at ICON, you will provide strategic and operational leadership for our global study start-up organization, ensuring the timely, compliant, and efficient initiation of clinical trials across diverse customer portfolios. Serving as the executive leader for sponsor-facing study start-up delivery, with FSA teams acting as the primary client interface coordinating execution across Site Selection, Regulatory Affairs, Contracts, Site Activation, and other key functional areas.
Director, Regulatory Affairs, Ex-Us Larimar TherapeuticsDirector, Regulatory Affairs, Ex-UsPhiladelphia, PAPrepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings. Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.