- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... from higher-level manager. Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... and/or arbitrator on global projects.Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within the company… more
- J&J Family of Companies (Columbus, OH)
- Associate Director , CMC Regulatory Affairs -...Authorities under supervision of a senior member of the CMC RA staff. + Strong knowledge of ... 2406221330W **Description** Johnson & Johnson is recruiting for an Associate Director , CMC Regulatory Affairs . This position can be located in Spring… more
- Gilead Sciences, Inc. (Foster City, CA)
- …liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. ** Director , CMC Regulatory Affairs - Biologics** ... **Key Responsibilities:** The Director , CMC Regulatory Affairs for Biologics is responsible for defining regulatory strategy for one or more… more
- AbbVie (North Chicago, IL)
- …to support regulatory submissions. + Work closely with Regulatory Affairs to ensure alignment of expectations for CMC control strategies in submissions. ... Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director of CMC Dossier Leadership will lead...team responsible for the creation and management of high-quality CMC submission strategies and Module 3 regulatory … more
- Amgen (Thousand Oaks, CA)
- …Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global CMC ** **What you will do** Let's do ... years of regulatory experience **Preferred Qualifications:** + Substantial experience leading CMC Regulatory Affairs strategy and execution for biologic… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Executive Director and Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will contribute:** + Leads the ... CMC teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives....in conjunction with direct reports, manages resources, establish a CMC RA strategy and collaborate with stakeholders… more
- Regeneron Pharmaceuticals (Troy, NY)
- …for assigned cell and gene therapy portfolios. This role includes overseeing regulatory affairs staff, various outside contractors, supporting project teams and ... typical day might include:** + Direct activities of assigned Regulatory Affairs team with emphasis on global...policies + Provide and drive strategic and operational global CMC regulatory direction and documentation for portfolio… more
- AbbVie (North Chicago, IL)
- …is required. + Ability to influence internal and external experts on CMC regulatory issues, independently. + Demonstrated excellence in writing, presentation, ... (https://www.tiktok.com/@abbvie) . Job Description Purpose Full time/dedicated responsibility for CMC leadership and project management for commercial and pipeline… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to ... higher-level manager. + ** Regulatory Knowledge:** Demonstrates expert knowledge of US/EU regulatory guidances. Serves as RA CMC representative supporting… more
- Actalent (Boston, MA)
- …Masters, PharmD, or PhD preferred. + Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, ... *Gene therapy experience preverred* Responsibilities: + Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position** Reporting to the Director or Executive Director in Organon Regulatory CMC New Products, the Associate Principal ... Scientist (Associate Director ) is responsible for Regulatory Chemistry Manufacturing & Controls ( CMC ) aspects of clinical phase through market product… more
- Takeda Pharmaceuticals (Boston, MA)
- …Establish collaboration with Takeda teams and leadership through networks and enable CMC regulatory team's success in meeting goals/objectives on drug-device ... across a complex matrix environment in GRA with GRLs, CMC RA project leads and other GRA...in pharmaceuticals and/or medical devices industry including experience in regulatory CMC ; international experience is a plus… more
- Gilead Sciences, Inc. (Foster City, CA)
- …+ Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks. + ... possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC ...Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** **_*This is a site… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...requests, and briefing documents. + Acts as liaison between Regulatory Affairs and other functional areas, including… more
- Amgen (Washington, DC)
- …over 10 million patients worldwide. It's time for a career you can be proud of. ** Regulatory Affairs Director - Global Regulatory Leader - Oncology** ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in the Oncology Therapeutic Area.… more
- Ascendis Pharma (Palo Alto, CA)
- …a dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and ... implementing global regulatory strategies encompassing clinical, non-clinical and CMC ...complex and require extensive interaction with departments outside of regulatory affairs . + Excellent organizational skills and… more
- Amgen (Washington, DC)
- …Amgen team. Join us and transform the lives of patients while transforming your career. ** Regulatory Affairs Director - Global Regulatory Lead** **What ... you will do** Let's do this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global … more
- Danaher Corporation (Chicago, IL)
- … Affairs department and report to the Vice President of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...the authoring, review and support of client filings including CMC submission in INDs, BLAs, NDAs, etc. + Primary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT (Global Project Team), Daiichi ... global projects. + Interface with clinical and pre-clinical groups, Regulatory CMC and other appropriate groups within...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
