- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Takeda Pharmaceuticals (Boston, MA)
- … vaccine programs in various stages of development + Represents the vaccine regulatory affairs team on cross-functional Takeda Vaccines teams to ensure that ... product developmentprogramspreferred + Sound understanding of scientific principles and regulatory CMC requirements relevant to global vaccine development,… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …address some of the most challenging global health issues. The **Senior Director , Clinical Affairs , Diagnostic Solutions** reports directly to the Sr. ... Director , Global Medical Affairs - Strategy & Business...in the development and submission of clinical reports to Regulatory Affairs + Provide guidance to … more
- Gilead Sciences, Inc. (Foster City, CA)
- …in Liver, Inflammation, Respiratory Viruses, and Established Products (LIVE) to join our Global Medical Affairs team. This role is responsible for leading the ... CA location. **Specific Job Responsibilities** + Lead development of the Medical Affairs Research - LIVE strategic approach for data generation in alignment with… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. + Responsible… more
- BeOne Medicines (Harrisburg, PA)
- …or/and medical device is a plus. * In-depth knowledge of ICH requirements, global regulatory CMC requirements; Knowledge/experience in Quality Assurance and GMP ... processes. The individual manages direct reports of 10+ and reports to global head of regulatory CMC. **Essential Functions of the job:** * Lead, develop, and… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Director , Clinical Development and Medical Affairs (Respiratory) Requisition JR000014860 Director , Clinical Development and Medical Affairs ... Location Bridgewater, NJ Additional Locations Job Description Summary Job Description The Director of Clinical Development and Medical Affairs ( Respiratory)… more
- AbbVie (Mettawa, IL)
- …compliance with regulatory and ethical standards. . Collaborate with Regulatory Affairs , Legal, Compliance, and Pharmacovigilance teams to ensure adherence ... be willing to come onsite 3 days per week in Mettawa, IL. The Medical Director , Medical Affairs serves as a strategic medical and scientific expert within the… more
- J&J Family of Companies (Horsham, PA)
- …for Medical Director , Dermatology to join our US Immunology Medical Affairs organization in** **Horsham, PA** . **Purpose:** As part of US Immunology Medical ... Affairs , the Medical Director , Dermatology, will serve...regulatory documents, as applicable. In addition, the Medical Director , Dermatology will partner with colleagues in real-world value… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **JOB SUMMARY** The Senior Director , Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... + Marketing/ commercial + GMP QA/ Supply chain / Regulatory Affairs **Leadership/** **team** **management:** + Createahighperformingteamenvironmentandacohesiveculturedrivenbyvaluesof… more