- J&J Family of Companies (Spring House, PA)
- …recruiting for Associate Director , North America Regulatory Lead in Global Regulatory Affairs , supporting programs in the Immunology Therapeutic ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be...strategy through participation in product-related teams. + Provides regional regulatory input to the Global Regulatory… more
- J&J Family of Companies (Horsham, PA)
- Senior Director , CMC Regulatory Affairs ...to achieve quality and efficiency across and beyond the global regulatory affairs function. + ... **Description** Johnson & Johnson is recruiting for a Senior Director , CMC Regulatory Affairs Biologics...New Modalities oversees the development and execution of the global CMC regulatory strategy for biological products… more
- Merck (North Wales, PA)
- …Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical...someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is… more
- J&J Family of Companies (Horsham, 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
- Merck (North Wales, PA)
- …standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... **Job Description** Reports to the Director /Senior Director in the Office of...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… 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 ... 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
- Organon & Co. (Lansdale, PA)
- …regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation ... **Job Description** **The Position** Reporting to the Executive Director in Organon's Regulatory Chemistry, Manufacturing and Controls (CMC) New Products, the… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... implementing process changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues and Global … more
- J&J Family of Companies (Titusville, NJ)
- …Update training, Promotional Review Copy (PRC) Meetings, Health Care Compliance Teams, Global Regulatory Functional Teams, Product Labeling Teams and Compound ... Associate Director , Regulatory Advertising & Promotion -...Location** NA-US-New Jersey-Titusville **Organization** Johnson & Johnson Services Inc. (6090) **Job Function** Regulatory Affairs **Req ID:**… more
- J&J Family of Companies (Horsham, PA)
- …multi-disciplinary teams such as Copy Approval Committees, Business Leadership Boards, Global Regulatory Teams, Product Labeling Teams and Compound Development ... Director , Regulatory Advertising & Promotion -...**Primary Location** NA-US-Pennsylvania-Horsham **Organization** Johnson & Johnson Services Inc. (6090) **Job Function** Regulatory Affairs **Req ID:**… more
- Merck (Upper Gwynedd, PA)
- …internal partners including HH, our Research & Development Division **,** Medical Affairs , Market Access, Regulatory Affairs , Legal & Compliance, ... diagnostics and pharma? Then you could be our new Global Marketing Director , Precision Medicine. **The position:**...the use of the diagnostic test together with Medical Affairs and key R&D functions + Working effectively with… more
- Merck (Upper Gwynedd, PA)
- …cross-functional internal partners including Human Health, our Company's Research Labs, Medical Affairs , Market Access, Regulatory Affairs to successfully ... both diagnostics and pharma? Then you could be our new Global Marketing Director , InLine Dx, Precision Medicine. **The position:** We are currently recruiting… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …+ 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
- 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
- Pfizer (Collegeville, PA)
- …and discusses data at relevant team, governance, external consultants, KOL and potentially regulatory meetings. + Represents TA Clinical Affairs and may take the ... one or more specialty or primary asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS… 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
- 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 25% travel ... Johnson & Johnson, we all belong. As a member of Hematology Oncology (HemeOnc)Medical Affairs , the Associate Medical Director , Lymphoma & Leukemia will assist in… 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
- Merck (North Wales, PA)
- … Medical and Value Capabilities (GMVC) in Global Medical and Scientific Affairs (GMSA) that reports directly to the Director , Medical Operations, Innovation ... regulatory guidelines and compliance requirements pertaining to Medical Affairs operations, and, preferably, experience in navigating regulatory challenges… 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