NewBUSINESS MANAGER Abraxas Youth & Family ServicesBUSINESS MANAGERSouth Mountain, PA$70,000–$75,000Develop and implement processes to track patient admissions, utilization of services, and discharges and supervise patient billing systems and appropriate office staff members at the program/facility and other sites. Oversee financial operations and implementation with full charge accountant responsibilities including accounts receivable, accounts payable, billing, payroll, budget preparation (local and state-wide), and insurance.
Inpatient Care Manager, Registered Nurse (RN) or Social Worker (MSW), Per Diem, Miners Campus St. Luke's Health Network, Inc.Inpatient Care Manager, Registered Nurse (RN) or Social Worker (MSW), Per Diem, Miners CampusCoaldale, PAPart timeThe Social Worker Care Manager per diem is responsible for coordinating the complex discharge planning needs of patients, as well as to provide supportive The Social Worker or Registered Nurse Care Manager is responsible for coordinating the complex discharge planning needs of patients, as well as to provide supportive counseling, psycho-social assessment, and interventions for designated patient populations across the continuum of care. Individually and together, our employees are dedicated to satisfying the mission of our organization which is an unwavering commitment to excellence as we care for the sick and injured; educate physicians, nurses and other health care providers; and improve access to care in the communities we serve, regardless of a patient's ability to pay for health care.
Project Manager Page GroupProject ManagerHarrisburg, PA$95,000–$140,000 / yearFull timeThe Project Manager role in the property industry focuses on overseeing construction projects from initiation to completion, ensuring they meet quality, budget, and timeline expectations. A successful Project Manager should have: Proven experience in project management within the construction sector.
Program Manager, Regulatory Affairs Olympus CorpProgram Manager, Regulatory AffairsPAResponsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America.
Senior Quality and Regulatory Manager Colorcon IncSenior Quality and Regulatory ManagerNorth Wales, PAThe Senior Quality and Regulatory Manager reports directly to the Site Director for West Point and No-Tox and maintains matrixed responsibilities to Global Quality, with dotted line reporting to the Global Head - Innovation, Quality and Regulatory Affairs. This role is critical in ensuring product integrity, regulatory compliance, and operational excellence across both manufacturing sites while aligning quality and regulatory objectives with business goals.
Group Manager, Regulatory Affairs Globus Medical, Inc.Group Manager, Regulatory AffairsAudubon, PAThe Group Manager, Regulatory Affairs oversees the preparation and submission of regulatory premarket applications, and gains 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. + Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
Principal Regulatory Affairs Project Manager, Medical Devices West Pharmaceutical Services IncPrincipal Regulatory Affairs Project Manager, Medical DevicesExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
Regulatory Affairs Manager Lanxess AGRegulatory Affairs ManagerPittsburgh, PALANXESS has achieved leading positions in the Dow Jones Best-in-Class Index and the MSCI ESG and ISS ESG ratings, among others, for its commitment to sustainability. 5 to 10 years experience in the regulatory field with technical knowledge of the current FIFRA and PMRA regulatory requirements, procedures and guidelines for Registration of biocides by the U.S. EPA, state agencies and PMRA.
Senior Regulatory Project Manager ICON PlcSenior Regulatory Project ManagerBlue Bell, PAAs a Senior Manager, Regulatory Strategy at ICON, you will design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
Manager, Regulatory Affairs Globus MedicalManager, Regulatory AffairsAudubon, PennsylvaniaGuides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing. Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement.
Senior Project Manager - Quality & Regulatory Transformation Zp Group LlcSenior Project Manager - Quality & Regulatory TransformationPAThis 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.
Sr. Manager, Technical Regulatory Compliance Johnson & JohnsonSr. Manager, Technical Regulatory ComplianceWest Chester, PAThe position plays a critical role in managing compliance risk, supporting audit and inspection readiness, and enabling compliant execution of complex technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, Manufacturing, and IT teams. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.
NewSenior Manager, North America Regulatory Liaison Johnson & JohnsonSenior Manager, North America Regulatory LiaisonSpring House, PennsylvaniaAnalytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities.
NewSenior Manager, North America Regulatory Liaison 6084-Janssen Research & Development Legal EntitySenior Manager, North America Regulatory LiaisonSpring House, PennsylvaniaAnalytical Reasoning, Business Writing, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Mentorship, Organizing, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility This role will partner closely with global and cross-functional leaders to shape development pathways, influence key decisions, and ensure high-quality, timely interactions with Health Authorities.
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 Manager, Regulatory Affairs West Pharmaceutical Services IncSenior Manager, Regulatory AffairsExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. This role serves as a key bridge between regulatory experts, quality, commercial teams, and external clients to enable consistent, high‑quality execution of contracted regulatory deliverables.
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.
Sr. Regulatory Policy Manager Talen Energy CorpSr. Regulatory Policy ManagerAllentown, PASupport the regulatory needs associated with Talen development activities, including, but not limited to, identifying the applicable rules and assessing any potential impacts to the project, serving as a liaison to the RTO/ISO and completion of necessary filings and follow-up responses. This role will represent Talen Energy, and be an Advocate for Talen interests in the various Regional Transmission Organizations (RTOs) and states where Talen does business, and before Federal and State regulatory bodies and industry organizations, as necessary.
Digital Assets Regulatory Management Manager Deloitte Touche Tohmatsu LtdDigital Assets Regulatory Management ManagerPA$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.
Mgr, Advocacy, Product Stewardship & Regulatory Affairs AGC IncMgr, Advocacy, Product Stewardship & Regulatory AffairsExton, PAThis role supports-and increasingly leads-product stewardship, regulatory compliance, and market access activities across the Americas, while advancing the company's policy priorities, shaping regulatory frameworks, and ensuring a supportive legislative and regulatory environment for our products. This position will advocate for our product portfolio at the U.S. federal and state levels, develop and execute North America advocacy strategies, and coordinate closely with global teams to ensure alignment on regulatory and policy priorities.
Senior Regulatory Project Manager - Animal Health Cencora IncSenior Regulatory Project Manager - Animal HealthPAIn this role, you will partner with internal regulatory teams and client stakeholders to coordinate regulatory activities, monitor project delivery, facilitate communication across cross-functional teams, and help ensure timely execution of key regulatory operations. We are seeking a highly organized, proactive, and client-focused Senior Regulatory Project Manager - Animal Health to provide operational leadership and project management support across U.S. regulatory programs.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerCollegeville, PA$144,375–$240,625 / yearGSK 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. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
Regulatory Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerPA$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.
Manager, Financial Statement and Regulatory Reporting The Citco Group LtdManager, Financial Statement and Regulatory ReportingMalvern, PAAbout You: 4-6 years of experience in an Accounting Firm, Hedge Fund, Private Equity Administrator, Audit, or other financial institution where you have gained financial products knowledge. From working exclusively with hedge funds to serving all alternatives, corporations and private clients, our organization has grown immensely across asset classes and geographies.
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.
Quality and Regulatory Affairs Manager DENTALEZQuality and Regulatory Affairs ManagerLancaster, PAFull timeEnsures that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that internal and external audits are performed per current regulatory guidelines/procedures. Advisespersonnel and projectteams on quality system and regulatoryrequirements, coordinatesand presentsregulatoryinformation, and negotiates with and influencesmanagement and colleagues to ensurerequirementsare met.
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.
Sr. Regulatory Policy Manager Talen EnergySr. Regulatory Policy ManagerAllentown, PennsylvaniaThis role is ideal for a regulatory professional coming from industry operations, or ISO/RTO engagement who enjoys working directly with market rules, and will represent Talen Energy, to be an Advocate for Talen interests in the various Regional Transmission Organizations (RTOs) and states where Talen does business, and before Federal and State regulatory bodies and industry organizations, as necessary. In this role, you will move beyond high‑level policy monitoring and serve as a day‑to‑day regulatory partner to the business, including: Interpret, apply, and operationalize RTO/ISO market rules supporting generation assets, market participation, and commercial strategy across wholesale (and where applicable, retail) markets.
Senior Environmental Regulatory Permitting Manager (FERC) Stantec IncSenior Environmental Regulatory Permitting Manager (FERC)PAProvide technical leadership and project management for oil & gas midstream permitting projects (FERC-regulated natural gas or liquids pipeline projects) and energy transition projects throughout the US. Primary Location: United States | TX | Houston Other Locations: United States | PA Organization: BC-2353 EnvSvcs-US Gulf West Employee Status: Regular Business Justification: Replacement Travel: No Schedule: Full time Job Posting: 16/07/2026 01:07:03 Req ID: 1006748.
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.
Project Manager- Regulatory at Penn Medicine Penn MedicineProject Manager- Regulatory at Penn MedicinePhiladelphia, PAProvide demonstrations, presentations and formal classes as necessary; Provide periodic written status reports to the Director and Associate Director of Regulatory and Project Committees showing status compared to the work plan, issues, risk, and assignments/plans for resolution, resolved issues, problem log and status, upcoming major project situations, and adherence to project budgeted resources; Build and maintain databases and dashboards that support the work of the Regulatory Director as required. collates and assembles reports and documents as required by Director of Regulator; Draft and edit, PowerPoint presentations, scripts, talking points, leadership messages, and other communications as relates to both internal and external outreach; Ensure messages are appropriately written for targeted audiences.
Food Safety Program Manager - Regulatory Support Chewy IncFood Safety Program Manager - Regulatory SupportWilkes-Barre, PAWhat You'll Need: BS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is; required; Advanced MS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is preferred; Minimum of 2+ years in Food Safety and Quality Control in a distribution, warehousing, and/or manufacturing setting. The Regional Food Safety Specialist will; be responsible for; partnering with the Site Operations team, Continuous Improvement, Learning, Quality, and Facility teams to manage the deliverables; required; at the FC network.
Financial & Regulatory Reporting Associate Manager U.S. BancorpFinancial & Regulatory Reporting Associate ManagerPA$98,345–$115,700 / 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.
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.
Senior Analyst - Compliance & Regulatory Affairs AXA SASenior Analyst - Compliance & Regulatory AffairsEXTON, PA$64,600–$107,300 / yearBy combining a comprehensive and efficient capital platform, data-driven insights, leading technology, and the best talent in an agile and inclusive workspace, empowered to deliver top client service across all our lines of business - property, casualty, professional, financial lines and specialty. You will report to the Manager Regulatory Compliance Services What you will BRING Were looking for someone who has these abilities and skills: Required Skills and Abilities Property & Casualty Insurance experience in the field of regulatory compliance, state filings, product development, underwriting or underwriting support.
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.
Specialist 3 - Regulatory Affairs LancesoftSpecialist 3 - Regulatory AffairsWest Chester, PA$1Understand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division orthopedic devices.
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.
Regulatory Affairs Director IQVIA Holdings IncRegulatory Affairs DirectorWayne, PA$128,800–$358,800 / yearThe actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate to produce consistent results.
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.
Product Stewardship and Regulatory Affairs Sp AGC IncProduct Stewardship and Regulatory Affairs SpExton, PAEssential Functions: Supports new product registrations for Americas region, e.g., TSCA PMN/LVE/Polymer Exemptions, and Canadian DSL/NDSL notifications in close collaboration with R&D and global product stewardship teams. The position is part of a global highly interactive, diverse, and supportive team and will manage product stewardship activities to enable sales of new products and maintain the right to operate with existing products.
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.
Specialist 3 - Regulatory Affairs Katalyst Healthcares & Life SciencesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
Specialist 3 - Regulatory Affairs Karwell TechnologiesSpecialist 3 - Regulatory AffairsWest Chester, PAUnderstand, investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in order to assess regulatory implications for approval. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities for division Orthopedic devices.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsCollegeville, PA$113,850–$189,750 / yearGSK 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. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Vice President, Regulatory Affairs Cabaletta Bio IncVice President, Regulatory AffairsPhiladelphia, PARegulatory Submissions & Compliance Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development. Team Leadership Build and manage a high-performing regulatory affairs, operations, writing, and CMC regulatory with expertise in cell and gene therapy.
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.
Senior Counsel, Compliance, Regulatory & Quality West Pharmaceutical Services IncSenior Counsel, Compliance, Regulatory & QualityExton, PAWest solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. Reporting to and working in close partnership with our General Counsel and Chief Compliance Officer, this role is a key legal advisor to the Company in the area of overall Compliance, including privacy, and helps to oversee and manage West's global compliance program.
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.