- Merck & Co. (Rahway, NJ)
- … Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of ... Job Description Associate Director , Regulatory Submissions...user requirements, workflows, and metadata standards. Ensure compliance with global regulatory standards and internal SOPs for… more
- Insmed Incorporated (NJ)
- …for each other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs , CMC will be responsible for ... understanding of US, EU, and Japanese regulations for human drugs/biologics.Knowledge of global regulatory guidance documents and regulations with emphasis on… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team.- The ... Skills: Accountability, Adaptability, Biological Sciences, Cross-Functional Teamwork, Drug Development, Global Strategy, Innovation, Regulatory Affairs … more
- Organon & Co. (Jersey City, NJ)
- …**The Position?** Reporting to the Director in Organon Regulatory CMC,?the Associate Principal Scientist is responsible for?developing and?implementing ... questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines.Develop quality… 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** We are looking for an experienced Associate Director , Program Manager to join our team. This successful candidate will ... in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.)...live their best lives. We are a $6.5 billion global healthcare company focused on making a world of… more
- Organon & Co. (Plymouth Meeting, PA)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls (CMC), the Associate Principal Scientist is ... strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation… more
- Takeda Pharmaceuticals (Boston, MA)
- …to transformative 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
- J&J Family of Companies (Raritan, NJ)
- …Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Regulatory Affairs Diagnostics. This position is ... We invite candidates from any location to apply. The Associate Director , Global Regulatory Affairs Diagnostics will provide an opportunity to… more
