- Merck & Co. (Rahway, NJ)
- … CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. ... medical device or combination product research, development and/or manufacturingExperience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device… more
- Boehringer Ingelheim (Ridgefield, CT)
- …is seeking a dedicated and innovative Director /Senior Associate Director , Global Regulatory Affairs CMC for Chemical products to join our dynamic ... Boehringer Ingelheim's high regard for our employees. The GRL CMC Director or Senior Associate Director...requiring extraordinary regulatory expertise within Group Global CMC Regulatory Affairs . + Support… more
- Takeda Pharmaceuticals (Boston, MA)
- … CMC team, you will report to the Senior Director Global Regulatory Affairs CMC . **How you will contribute:** + Independently plan, execute and ... life-changing therapies to patients worldwide. Join Takeda as a Director , GRA CMC Small Molecules where you...where you will oversee the development and execution of regulatory CMC development and registration strategies. RA… more
- AbbVie (North Chicago, IL)
- …and LinkedIn. Job Description The Associate Director Regulatory Affairs , Chemistry, Manufacturing and Controls ( CMC ) works with internal and external ... procedures. Analyzes and approves manufacturing change requests. + Represents CMC regulatory affairs on teams...may be considered for the Senior Manager or Associate Director level based on qualifications. This role is hybrid… more
- AbbVie (North Chicago, IL)
- …experience + Preferred: 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing, ... YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA CMC Post Approval Change Dossier Manager is… more
- Merck (Columbus, OH)
- … CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. ... control activities and documentation reviews + Provide evaluations of regulatory state of affairs of any devices...combination product research, development and/or manufacturing + Experience in CMC regulatory (IND, CTA, BLA, MAA) with… more
- Lilly (Indianapolis, IN)
- …for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC Biotechnology will leverage CMC ... technical knowledge and regulatory science expertise to drive regulatory CMC strategies and develop submissions for marketing authorizations for the… more
- Regeneron Pharmaceuticals (Tarrytown, 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
- Gilead Sciences, Inc. (Foster City, CA)
- …and help create possible, together. **Job Description** **Associate Director , Analytical Regulatory Sciences, Systems & Operations in CMC Reg Affairs :** ... be accountable for the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. **Job… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …you will provide regulatory leadership and oversight to the development of innovative regulatory affairs and CMC regulatory strategies, guidance and ... and internal stakeholders. **A typical day as an Executive Director might look like:** + Responsible for the strategic...for the strategic company guidance on FDA and global regulatory requirements ( affairs and CMC )… more
- Sumitomo Pharma (Columbus, OH)
- …are currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Director Regulatory Affairs ** . The Director is part ... of the Global Regulatory Affairs (GRA) team based in the US. He/she will...collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, clinical protocols/study reports,… more
- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs ** . The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/she is...with colleagues, fostering collaboration, and idea sharing + Reviews CMC documentation (eg CMC information/data) and contributes… 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)
- …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
- 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
- Gilead Sciences, Inc. (Foster City, CA)
- …help create possible, together. **Job Description** The Data Governance Lead for Regulatory Affairs will be responsible for defining, implementing, and ... overseeing data governance strategies and frameworks within the regulatory affairs domain. Regulatory information assets are a core asset for regulatory … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory ... 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
- CSL Behring (King Of Prussia, PA)
- …used to treat serious and often rare conditions. Could you be our next Associate Director , Global Regulatory Affairs ? The job is located in our King ... is a hybrid position. You will report to the Director of Global Regulatory Affairs ....GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads to enhance these relationships. May serve… more
- Danaher Corporation (Fargo, ND)
- … 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
- AbbVie (South San Francisco, CA)
- …technologies to discover and develop novel cancer treatments. We are currently seeking a Regulatory Affairs Director to join our growing regulatory ... strategies for oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed...preferred. + 8 - 12 years of experience in Regulatory Affairs (strong preference for experience in… more
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