- Merck & Co. (North Wales, PA)
- …of best practices in those areasU.S./ Global experience in clinical research, regulatory affairs , scientific and medical affairs , or pharmaceutical ... and Development Division, Value & Implementation Human Health, Manufacturing Division, IT Global Medical Proficiency and External Affairs (GMPEA) Global … more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …strategy.Collaborate closely with internal functions such as Pharmacology, CMC, Regulatory Affairs , Clinical, and Program Management.Maintain up-to-date ... Legend Biotech is a global biotechnology company dedicated to treating, and one...the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… more
- Insmed Incorporated (NJ)
- …E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory affairs , drug development, FDA and regulatory guidelines (ie, ... functional impact metrics.Cross-functional Alignment - Partner across all of Medical Affairs , particularly with Global Medical Strategy, Regions, Field Medical,… more
- Insmed Incorporated (NJ)
- …and QC of regulatory documents prior to submission.Ensure adherence to global regulatory authority technical requirements (FDA, EMA, Health Canada, MHRA, ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC, Clinical, Quality) to facilitate document… more
- Cipla (Fall River, MA)
- …committee, commercial, portfolio, R&D technical staff, supply chain management, medical affairs , regulatory affairs , quality assurance, procurement etc. ... only - is not for those applying for a global assignment and/or for employees working outside of Cipla's...In collaboration with Cipla commercial, supply chain management and regulatory affairs , responsible for launch planning, launch… more
- Boehringer Ingelheim (Ridgefield, CT)
- …lead the Regulatory Excellence Team (RET) and represent Global Regulatory Affairs (GRA) on the Evidence Team. The Director , Global Regulatory ... reflect Boehringer Ingelheim's high regard for our employees. The Director , Global Regulatory Strategy Lead...RA sub team / RET to accurately reflect global regulatory requirements and challenges in the… more
- Amgen (Washington, DC)
- …best work alongside other innovative, driven professionals in this meaningful role. ** Regulatory Affairs Senior Director - Global Regulatory Leader - ... In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership,… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director , Global Regulatory Lead Oncology where you will be part ... of the global regulatory team. As Associate Director...regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization… more
- BeOne Medicines (San Mateo, CA)
- **General Description** **_:_** + The Director , Global Regulatory Lead, will be responsible for developing, implementing, and advising on global ... global development, regulatory , and registration strategies. + The Director , Global Regulatory Lead supporting programs within BeOne's Hematology… more
