GRA CMC Specialist CSLGRA CMC SpecialistKing of Prussia, PASupport the collaboration with CSL’s Corporate & External Affairs organization to support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies. Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work.
Safety Specialist JobotSafety SpecialistNorristown, PA$90,000–$120,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. An established and rapidly growing commercial construction management firm is seeking an experienced Safety Specialist to support a large-scale, campus-based construction project.
NewSenior Field Supply Chain Specialist - Contract TalentBurst, Inc.Senior Field Supply Chain Specialist - ContractWilmington, DE$37.93–$59.85 / hourThe role focuses on executing Business Integration Testing (BIT) and User Acceptance Testing (UAT) by generating and validating label outputs across SAP environments. Client is seeking an experienced SAP GLM Specialist within the Supply Chain Data organization to support Global Label Management and SAP EHS activities.
NewDigital Marketing Specialist ECLARODigital Marketing SpecialistLawrence Township, NJ$81.74–$86.69 / hourIf needed, lead internal MLR review processes and work with external partners to ensure timely and accurate preparation of digital programs (e.g., CRM, third-party programs, HCP media, websites, mobile, email, social media, SEO / SEM, IVA, Field-Trigger e-mails, etc.). Position Overview: The Omnichannel Strategist serves as a dedicated point-of-contact for a brand, their creative, digital and media agencies, ensuring seamless planning and execution of omni-channel campaigns / tactics aligned to the brand strategy.
NewPharmacovigilance (PV) Analytics and Reporting Specialist ECLAROPharmacovigilance (PV) Analytics and Reporting SpecialistLawrenceville, NJResponsibilities: Data Analytics and Reporting Build and continuously improve data analytics through supporting models that provide insights into efficiency, quality, stakeholder feedback, and key performance indicators to drive timely and informed decision making. The PV Analytics and Reporting Specialist, PV Analytics Center of Excellence applies a combination of life sciences strategy, leadership, and reporting/visualization experience to drive successful servicing of information needs across PS.
Clinical Specialist JouléClinical SpecialistExton, PAThe ideal candidate will be the go-to expert for device training, therapy education, and enrollment support, ensuring that the trials are conducted with the highest level of clinical integrity. We are looking for a seasoned Registered Respiratory Therapist (RRT) with a strong background in clinical research to join our client's team in a high-impact, mobile role.
NewSpecialist Director, Cloud Security KPMGSpecialist Director, Cloud SecurityPhiladelphia, PA$169,005–$370,530 / yearResponsibilities: Provide strategic leadership for cloud security governance across AWS and Azure environments, including oversight of security posture, risk remediation, compliance, and continuous monitoring programs; Lead enterprise cloud asset, firewall, and security exception governance programs, including inventory accountability, lifecycle management, policy compliance, risk acceptance, and regulatory oversight. Set the strategic direction for secure adoption of cloud and AI-enabled technologies by establishing security baselines, guardrails, policies, and control frameworks; Partner with cloud, cybersecurity, architecture, and business leaders to embed security into platform strategy, architecture decisions, and enterprise cloud transformation initiatives.
NewCopilot Studio Specialist CollaberaCopilot Studio SpecialistPennington$70–$73 / hourTemporaryContractorYou’ll help drive enterprise adoption of Copilot Studio by building AI agents, automations, and integrations while ensuring alignment with AI governance and best practices. As a global leader in talent solutions, we provide opportunities to work with top organizations, cutting-edge technologies, and dynamic teams.
NewProcurement Project Specialist AtriumProcurement Project SpecialistWilmington, DE$35–$45 / hourThe Procurement Project Specialist manages sourcing initiatives, purchasing activities, supplier relationships, inventory planning, and cost savings programs while ensuring supply continuity, operational efficiency, and compliance with organizational requirements. Education Requirements: Bachelor's degree in Business, Supply Chain, Procurement, Operations, Finance, Engineering, or a related field, or equivalent professional experience is required.
NewProgram Specialist SevitaProgram SpecialistLevittown, PA$53,500–$55,000Manage the day-to-day operations of one to four programs in a community including organization and implementation of direct supports, person-centered planning, and implementation, health care, advocacy, stakeholder relations, regulatory compliance, recruiting, retention, staffing, training, safety, financial management, and maintenance of the physical environment. Manage the implementation of program planning; monitor delivery of services and supports; ensure services are consistent, engaging, and relevant to the individuals served.
NewUnderwriting Specialist OR Executive Underwriter - Middle Market Zurich Insurance Company Ltd.Underwriting Specialist OR Executive Underwriter - Middle MarketPhiladelphia, PA$79,600–$172,300Over the past five years, Zurich North America has built a world-class Middle Market operation that serves key industries across the U.S. We strive to assemble a team of dedicated Middle Market leaders and underwriters who understand this space very deeply and who grasp the unique challenges of the various industry segments and the individual customers we serve. In this role, you will serve as a customer advocate with a focus on improving customer experience by understanding their unique risks and offering the best end-to-end solution for their Property & Casualty insurance needs.
NewManager, Drug Product Manufacturing Larimar TherapeuticsManager, Drug Product ManufacturingMiddle East, PAPosition Summary: Reporting to the Head of Drug Product, CMC Technical Operations, the Manager/Senior Manager, Drug Product Manufacturing is responsible for overseeing external manufacturing operations and technology transfer activities for lyophilized biologic drug products supporting clinical and commercial supply. The successful candidate will provide technical leadership across drug product manufacturing, process validation, lifecycle management, and commercialization efforts while partnering closely with Technical Operations, MSAT, Quality, Regulatory Affairs, Supply Chain, Process Development, and external partners.
Traveling Recertification Specialist Pratum CompaniesTraveling Recertification SpecialistPhiladelphia, PARemote$22–$26 / hourFull timeAlthough the Washington DC Metropolitan area, including Virginia and Maryland are primarily be where support is needed, such that reliable transportation for regional travel is a requirement , - This role will require travel nationwide to support third party management clients, as well as supporting Pratum's portfolio within the Washington DC Metropolitan area, including Virginia and Maryland are primarily be where support is needed, such that reliable transportation for regional travel is a requirement, overnight and multi-day travel to any state for operational coverage is a requirement of the role. This role is non-exempt and has an anticipated hourly pay range of $22-$26/hour (~$45k-54k annually) for a new employee depending on a number of relevant factors including individuals’ experience, qualifications, knowledge, skills, abilities, client/property or company budgetary limitations/guidelines, and other job-related company and market considerations.
Senior Regulatory Affairs Specialist Integrated Resources, IncSenior Regulatory Affairs SpecialistWest Chester, PennsylvaniaContractorJob DescriptionClient: Direct ClientLocation: West Chester, PAJob Title: Senior Regulatory Affairs SpecialistDuration: 1 year + (Possible Extension)Job Summary:The Recall Regulatory Specialist III will be responsible for leading OUS (outside the US) field action execution activities including managing Field Action Strategy Team meetings, coordinating and preparing document packages to notify regulatory agencies of field action activities, drafting internal and external customer communications, providing updates to FDA and global regulatory agencies, processing and closing Field Actions in a timely manner, and act as support for FDA and regulatory inspections. Senior Regulatory Affairs SpecialistIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
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.
NewSenior Specialist, Regulatory Affairs, Medical Devices West Pharmaceutical Services IncSenior Specialist, Regulatory Affairs, Medical DevicesExton, PASpecialist is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, Post Market Submissions, China NMPA Registrations, Technical Documentation for CE Marking, technical packages. West 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.
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.
VP, Regulatory Specialist Marsh & McLennan Companies IncVP, Regulatory SpecialistPhiladelphia, PA$105,000–$192,500 / yearWe aim to attract and retain the best people and embrace diversity of age background, disability, ethnic origin, family duties, gender orientation or expression, marital status, nationality, parental status, personal or social status, political affiliation, race, religion and beliefs, sex/gender, sexual orientation or expression, skin color, veteran status (including protected veterans), or any other characteristic protected by applicable law. We will count on you to: Lead end-to-end regulatory filing activities, including scoping, drafting, compiling, submitting, tracking, and closing filings with state insurance departments and other relevant regulatory bodies.
Intrnatl Regulatory Specialist Globus MedicalIntrnatl Regulatory SpecialistAudubon, PennsylvaniaThis individual must be enthusiastic, positive, even-tempered and effective in building working relationships with cross-functional teams and international staff while following ISO, CE, FDA and international/local regulations. Partners with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files, and other international filings, to obtain marketing clearance.
INTRNATL REGULATORY SPECIALIST Globus Medical IncINTRNATL REGULATORY SPECIALISTPAThis individual must be enthusiastic, positive, even-tempered and effective in building working relationships with cross-functional teams and international staff while following ISO, CE, FDA and international/local regulations. Essential Functions: Partners with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files, and other international filings, to obtain marketing clearance.
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.
NewSenior Specialist, Regulatory Affairs West Pharmaceutical Services IncSenior Specialist, Regulatory AffairsExton, PASpecialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. West 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.
North America Product Stewardship & Regulatory Specialist DuPont de Nemours IncNorth America Product Stewardship & Regulatory SpecialistWilmington, DEWe're looking for a North America Product Stewardship & Regulatory Specialist to play a critical role in ensuring our products are safe, compliant, and positioned for sustainable growth across their lifecycle. Partner with global Tyvek product stewardship leaders and cross-functional teams (R&D, manufacturing, supply chain, marketing, legal, and sustainability).
Sr Regulatory Affairs Specialist Globus MedicalSr Regulatory Affairs SpecialistAudubon, PennsylvaniaPrepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances. Coordinates and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements.
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.
NewSenior Regulatory Affairs Specialist West Pharmaceutical Services IncSenior Regulatory Affairs SpecialistExton, 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 supports material change controls, internal and external customer regulatory requests, R&D product development, and maintaining knowledge of current US and international regulations/guidelines/policies applicable to West's products and services.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaPA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
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.
Sr. Specialist, Regulatory Project Management West Pharmaceutical Services IncSr. Specialist, Regulatory Project ManagementExton, PAThe Senior Specialist, Regulatory Project Management is responsible for leading regulatory project execution for West's global portfolio of medical devices, combination products, software-enabled devices/SaMDs, and packaging components. The role supports FDA premarket submissions (510(k)), EU MDR Technical Documentation, Master Files (DMF/MAF), change notifications, information request responses, post-approval commitments, and post-market regulatory deliverables.
NewSenior Specialist, Regulatory Operations West Pharmaceutical Services IncSenior Specialist, Regulatory OperationsExton, 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. Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
Regulatory Affairs Specialist IDE GroupRegulatory Affairs SpecialistPhiladelphia, PAt\t\t \t\t \t\tMenuMedTech SectorsConnected CareDrug DeliveryPoint-Of-Care DiagnosticsRespiratory CareSurgical DevicesCapabilitiesOpportunity DiscoveryBusiness StrategyProduct DevelopmentSoftware SolutionsQuality AssuranceRegulatory AffairsManufacturingMarket Launch & DistributionHuman Factors & Usability EngineeringMedTech Simulation Usability LabProjectsAboutCertifications & ComplianceHow We WorkOur TeamCareersJobsIntern & Grad ProgramsNews & MediaVideos & PodcastsBBFH SeriesPodcastsOther Videos & PodcastsPress ReleasesNews & ArticlesBBFH ChallengeOpportunity & PrizesKey DatesChallengersYour MotivationJudgesWinners 2025Interview SeriesOur ImpactContact\t\t \t\t\t. \t\t\t\t \t\t\t\t \t\t\t\t\tSearch for: \t\t\t\t\t\t\t\t\t\t\t\t\t \t\t\t\t\t\t\t\t\t\t\t \t\t\t\t \t\t\t\t \t\t\t\t\t \t\t\t\t\t\t\t\t\t.
International Regulatory Specialist Globus Medical IncInternational Regulatory SpecialistPAEssential Functions: Work in conjunction with other departments to develop submissions; Partner with Product Development, Quality Assurance, and management to prepare and review international regulatory submissions including CE technical files and design dossiers, and other international filings, to obtain marketing clearance; Obtain timely marketing clearance for all products in parallel with US submissions; Provide regulatory oversight of changes in manufacturing facilities, processes, and procedures, as they pertain to international regulations; Coordinate, review and submit product labeling for marketing outside the U.S. Review design changes and technical files for updates to documentation; Prepare and file certificates to foreign governments with FDA; Develop relevant regulatory SOPs as necessary; and. Experience preparing key regulatory deliverables, including Letters to File (LTF), Regulatory Release Memos, and Regulatory Analyses for FDA 510(k)-cleared products.
Regulatory Compliance Specialist J&J Snack FoodsRegulatory Compliance SpecialistMount Laurel, New JerseyAs a leader and innovator in the snack food industry for over 50 years, J&J Snack Foods provides branded snack foods to foodservice and retail supermarket outlets across the U.S. Its products include such icons as SUPERPRETZEL, ICEE, and Dippin’ Dots along with other key brands like LUIGI’S Real Italian Ice, The Funnel Cake Factory Funnel Cakes, and Hola Churros. ESSENTIAL FUNCTIONS: Verifies label content and provides approval on all finished product labels by applying a thorough knowledge of federal, state, local, and international food labeling requirements.
Senior Chemical Regulatory Compliance Specialist StratasysSenior Chemical Regulatory Compliance SpecialistButzbach, DEThe Senior Chemical Regulatory Compliance Specialist is responsible for ensuring that chemical substances and mixtures comply with applicable European and country-specific chemical legislation, including REACH, CLP, and related national requirements (e.g., Germany, UK, Netherlands, Switzerland, Turkey). The role supports multiple sites and technologies to ensure consistent regulatory compliance across the organisation and acts as a subject matter expert on EU chemical regulatory matters.
Clinical Pharmacy Specialist Regulatory--HUP Penn MedicineClinical Pharmacy Specialist Regulatory--HUPPhiladelphia, PAThe CPS-R will also participate in the design and implementation of management controls and practices to ensure that all business units are compliant with Federal, State and local rules and regulations, including, but not limited to, FMCSA, CA BIT, PHMSA, CSA, OSHA, FSMA, AIB and IFTA. Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine.
Specialist Actuarial Pricing, Regulatory AXA SASpecialist Actuarial Pricing, RegulatoryEXTON, PA$89,400–$148,600 / 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. AXA Hearts in Action: We have established volunteering and charitable giving programs to help colleagues support causes that matter most to them, known as AXA XL's "Hearts in Action" programs.
Regulatory Communications Specialist The Vanguard GroupRegulatory Communications SpecialistMalvern, PennsylvaniaCreate communications that enable and equip client-facing crew to discuss regulatory matters with clients with confidence (e.g., send text, positioning, discussion guides, FAQs, videos, etc.). The role supports the Workplace Solutions business which provides investment solutions and services to meet the needs of employers offering company-sponsored retirement plans and to improve the financial well-being of millions of investors.
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.
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.
NewRegulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemotePhiladelphia, PennsylvaniaRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
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.
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.
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.
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.
Associate Director, Promotional Regulatory Affairs AstraZeneca PlcAssociate Director, Promotional Regulatory AffairsWilmington, DE$150,098–$225,147 / yearAs the Associate Director Promotional Regulatory Affairs, you will ensure efficient and effective regulatory review and risk assessment of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, faculty training, Proactive Scientific Exchange by SciP, Corporate Affairs communications, and any other materials required to be reviewed through AZAP. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to help business teams develop and deliver initiatives that are intended to comply with applicable laws, rules and regulations governing the advertising and promotion of pharmaceutical products in the US.
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.
Regulatory Affairs Coordinator Capital HealthRegulatory Affairs CoordinatorHopewell, New JerseySUMMARY: 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.
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.
Regulatory Affairs Associate Integrated Resources, IncRegulatory Affairs AssociateMalvern, PennsylvaniaContractorJob Title: Regulatory Affairs Associate Duration: 3 Months+ Location: Malvern, PA Job Description: • Review Change Control • Compile and author Annual Reports • Build submissions in eCTD software • Update spreadsheets and Database as needed • Additional duties as requested • Support the Regulatory Affairs team in reviewing Change Controls, writing Annual Reports, updating spreadsheets and Databases as needed. Our methods include applying domain expertise in specific industry segments, utilizing a highly-skilled workforce, leveraging a proven global delivery model, implementing structured and scalable quality processes and methodologies and yet, staying cost-effective.
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.