- Merck (North Wales, PA)
- **Job Description** Our Diagnostics focused Regulatory Affairs team helps bring new precision medicine advancements to the world by facilitating effective, ... as appropriate, and corresponding therapeutic dossiers. + Interacting with global regulatory authorities and diagnostic partners to...devices, the majority of which must be in diagnostic regulatory affairs . Preferred: MS with minimum of… more
- Teva Pharmaceuticals (West Chester, PA)
- …a difference, and new people to make a difference with. **The opportunity** The Sr. Director , Global Regulatory Affairs CMC is responsible to oversee ... Senior Director Regulatory Affairs CMC...Senior Director Regulatory Affairs CMC (Biologic Products) Date:...major market health authorities as well as coordinating with global regulatory colleagues in preparing dossiers for… more
- J&J Family of Companies (Spring House, PA)
- Global Medical Affairs Leader, Director , Dermatology - 2406179906W **Description** Johnson & Johnson Innovative Medicine, Immunology Global Medical ... Affairs , is recruiting for a Global Medical Affairs Leader (GMAL), Director...Excellent knowledge of study execution, benefit risk management and regulatory affairs . + Proven ability to act… more
- J&J Family of Companies (Horsham, PA)
- …skills and the ability to influence is necessary * Experience interacting with global regulatory authorities is also desirable * Approximately 20% travel ... Associate Medical Director , Rheumatology Therapeutic Area - Medical Affairs...products. She/he will partner with colleagues from Commercial, R&D, Global Medical Affairs , Real-world Value & Evidence,… more
- Integra LifeSciences (PA)
- …what's possible and making headway to help improve outcomes. Reporting to the Sr. Director , Global Medical Affairs , Wound Reconstruction and Care, we are ... seeking a highly motivated and experienced **Medical Director , Wound Reconstruction and Care (WRC)** to join our...Responsible for approval of medical and scientific content of Regulatory , Safety, Medical Affairs , and Commercial inputs… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …and pharmaceutical services through our industry-leading brands. Position Summary Lead the global Regulatory Affairs (RA) team and provide organizational ... talent development within the team. Reporting to the Senior Director of Regulatory Affairs , the...compliance within LPE. Responsible for leading and developing the global RA team supporting LPE. Responsible for reviewing and… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …to Director , GRO Regulatory Project Management and be a part of the Global Regulatory Affairs Team. **How you will contribute:** + As Associate ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Project Management...changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues… more
- Sanofi Group (Swiftwater, PA)
- …+ Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team ... products within the Sanofi portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device Department within … more
- Pfizer (Collegeville, PA)
- We have an exciting opportunity for a Director to join our vaccines Global Regulatory Science team as a US Regional Regulatory Strategist (RRS). This is ... * Provide regional strategic regulatory expertise as regulatory representative to Global Regulatory ...Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Regulatory Affairs… more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Harrisburg, PA)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will...approvals. Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- J&J Family of Companies (Horsham, PA)
- …2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate Director Global Labeling Product Leader (1 of 2) in Raritan, NJ; ... Associate Director , Global Labeling Product Leader (1...experience. + Relevant experience in the pharmaceutical industry (eg, Regulatory Affairs , Clinical, Medical Information, Pharmacovigilance) including… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …auditor certifications that results in increased auditing capabilities. Knowledge in applicable global regulatory requirements, including but not limited to US ... on internal audit responses. + Experience working in a global organization and collaborating with multiple regions (Americas, EMEA,...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Organon & Co. (Plymouth Meeting, PA)
- …Officer, working directly with the US Federal and State Policy and Government Affairs teams, the Global Policy team, the US Commercial organization, Organon ... analysis and development as part of a proactive Government Affairs team. The Director will be primarily...to draft formal comments related to federal and state regulatory action. Develop public policy positions and cover policy… more
- Pfizer (Collegeville, PA)
- …Specialty Care Operational Excellence Director role is an integral member of the Global & US Medical Affairs Teams, and the Operational & Change Excellence ... Team. The Specialty Care Operational Excellence Director leads the development and implementation of key US...US Field Medical Lead and closely collaborates with the Global Medical Affairs and US Categories Medical… more
- J&J Family of Companies (Horsham, PA)
- …impeccable ethics, transparency and patient-focus. + Experience interacting with global Regulatory Authorities. + Management experience in supervising ... continuous improvement and developing trusting partnerships internally (eg R&D, Quality, Regulatory , Commercial, Legal, Medical Affairs ) and externally (eg… more
- Pfizer (Collegeville, PA)
- …Identify innovative digital and social media solutions that align to the impact the Global Medical Affairs strategy and shape the digital roadmap and quickly ... and relevance. **Cross-functional Collaboration around Medical Governance** Liaise with Global and US internal stakeholders, including Medical, Regulatory ,… more
- Teva Pharmaceuticals (West Chester, PA)
- …to and responsible for the clinical leadership of INDs, NDAs, BLAs, and other global regulatory filings. The Director will foster relationships with opinion ... as needed + Partners cross-functionally with departments such as Regulatory Affairs , Toxicology, CMC/Formulations, Biostatistics, Legal, Marketing,… more
- J&J Family of Companies (Spring House, PA)
- …clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical ... Data Monitoring Committee (IDMC) and adjudication meetings as needed. + Assists Regulatory Affairs in determining requirements for any corrective actions or… more
- J&J Family of Companies (Horsham, PA)
- Director , Medical Safety Officer, Solid Tumor Oncology - 2406194380W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, ... responsible for product safety and benefit risk oversight and represents Global Medical Safety (GMS) as the product spokesperson regarding overall benefit/risk.… more