- Actalent (Parsippany Troy Hills, NJ)
- Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC Regulatory Affairs Scientist, you will play a crucial role in the design and ... + Collaborate with pharmaceutical development and industrial operations teams to generate CMC regulatory dossiers. + Participate in industry working groups to… more
- Parexel (Oklahoma City, OK)
- …development and approved programs, helping to shape the future of life-saving therapies. As a ** CMC Regulatory Affairs Senior Associate** , you will play ... scientific discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. +… more
- Parexel (Providence, RI)
- …motivated professional to join our Global Regulatory Affairs team as a CMC Regulatory Affairs Senior /Consultant. This role is critical to ensure ... contingency plans for CMC -related scenarios * Represent CMC Regulatory Affairs in cross-functional...for a Consultant level role, 7+ years for a Senior Consultant * Proven success in preparing regulatory… more
- Gilead Sciences, Inc. (Foster City, CA)
- …a scientific or technical discipline required (advanced degree preferred) - with biopharma and/or regulatory affairs experience of 14+ years with a BA/BS or 12+ ... in digital or innovation roles preferred. + Strong understanding of CMC regulatory submissions and the structure/content of Module 3. + [Preferred]:… more
- Lilly (Indianapolis, IN)
- …patients who need them all over the world. The Advisor Post approval scientist in Global Regulatory Affairs - CMC Commercial Products will leverage CMC ... life better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs - CMC Pre-approval Small Molecules will leverage CMC ... make life better for people around the world. Lilly is looking for regulatory CMC scientists to join us in developing and bringing life-changing new medicines to… more
- Lilly (Indianapolis, IN)
- …them all over the world. The Senior Advisor/Director Post approval scientist in Global Regulatory Affairs - CMC commercial solid oral products will use ... better for people around the world. Lilly is looking for post approval regulatory CMC scientists to join us in delivering life-changing new medicines to patients… more
- Merck (Rahway, NJ)
- … CMC . This individual will be a senior member of the Regulatory Affairs CMC organization and will also manage significant cross-modality projects ... as an extension of the overall Regulatory Affairs CMC Leadership Team. This Lead plays a critical role in driving alignment and execution globally across… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and biomarker assay development and validation. + Collaborate with Global Manufacturing, Regulatory Affairs , and Global Quality to explore methods and implement ... and empower you to shine? Join us as a Senior Manager of Statistics- CMC in our...as appropriate in a timely manner. + Respond to regulatory questions that are statistical in nature. + Increase… more
- Bausch + Lomb (Juneau, AK)
- …in assigned due diligence activities for business development and acquisitions. + Lead all CMC regulatory activities for IND, NDA, ANDA, and BLA submissions. + ... Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to… more
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