- Merck & Co. (Rahway, NJ)
- Job Description Associate Director , Regulatory Submissions Archive Operations - Location: Rahway, NJ (Hybrid role - onsite 3 days per week required) - ... Regulatory Innovation and Information Management (RIIM) within Global Regulatory Affairs & Clinical Safety (GRACS)...Regulatory Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions… 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 ... have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy… more
- Merck & Co. (Rahway, NJ)
- …the direction of the GTD Director , the Associate Director will be responsible for developing multiple global brand name strategies ... prepare for these launches, we are looking for an Associate Director (AD) to join our center...obtain trademark approval in time for health authority submissions.Leads regulatory submission and rejection strategies for global ,… more
- Insmed Incorporated (NJ)
- …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 reviewing ... 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. (Millsboro, DE)
- …transfers for Animal Health vaccines across our US manufacturing network. As Associate Director , you will own end-to-end execution for Large Molecule/Biologics ... transfer leadsStrong understanding of cGMP, PPQ, validation (process/cleaning/CSV), and global regulatory frameworks (USDA)Excellent verbal and written… more
- Merck & Co. (Rahway, NJ)
- …execution, along with leadership skills to shape the technical capabilities lead a global , cross-modality technical team.The Associate Director will lead a ... into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be responsible… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Principal Scientist - Device Technical and Engineering Lead ( Associate Director Equivalent) Our company's Device Product & Process ... products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional… 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, ... we're in. Are you?About the Role:We're looking for an Associate , Regulatory Operations on the Regulatory...for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for… more
- Merck & Co. (Rahway, NJ)
- …BARDS Real-World Evidence (RWE) Capabilities & Analytics team is looking for an Associate Director , Data Strategy & Partnerships with expertise in data strategy, ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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
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