- Merck & Co. (Rahway, NJ)
- … Affairs & Clinical Safety (GRACS) - The Associate Director of Regulatory Submissions Archive Operations serves as the Business System Owner (BSO) for ... Job Description Associate Director , Regulatory Submissions Archive Operations -...seamless integration and governance of both digital and physical regulatory records, supporting audits, inspections, litigation, and business… 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 individual ... communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration… more
- Repligen (Waltham, MA)
- …contribution drives progress. Join us!We are seeking an experienced and driven IT Business Partner to represent our Manufacturing, Quality , Supply Chain, Product ... Development, and R&D organizations. As a Director of IT, you will play a key role...play a key role in aligning technology initiatives with business goals, driving efficiency, and enabling innovation across the… more
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs** , where you'll lead a talented team ... R\&D, and Quality teams. + Support commercialization efforts by ensuring regulatory readiness from concept to shelf. + Educate internal teams on competitive… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review + Lead and mentor team members +… more
- Novo Nordisk Inc. (Boulder, CO)
- … quality management systems (QMS). Provide direction & coordinate the Quality organization activities to support the business progress. Formulate, communicate ... quality programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory...align to the respective site's goals Meet or exceed business , regulatory & internal customer requirements in… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Insmed Incorporated (NJ)
- …team, partnering closely with heads of clinical operations, toxicology, regulatory affairs, commercial, pharmacovigilance, clinical quality , and ... we're in. Are you?About the Role:We're looking for an Executive Medical Director of Ophthalmology, Clinical Development to help us expand what's possible for… more
- Merck & Co. (Rahway, NJ)
- …with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and… more
- Formation Bio (New York, NY)
- …Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory , clinical pharmacology and project management to ... and manage drug product vendors, for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards.… more
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