- Larimar Therapeutics (Philadelphia, PA)
- …to science win the day - we welcome you! Position Summary: Larimar is seeking a CMC Regulatory Affairs Director to provide professional experience and ... Director . Job Duties/Responsibilities: Larimar Team Membership The Director of CMC Regulatory Affairs will be a key member of the regulatory ,… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and ... INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC ...preferred or equivalent relevant experience. Has 10-20 years of Regulatory Affairs experience as well as additional… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs , Tactical Implementation, you'll have a ... in. Are you?About the Role:We're looking for a Manager, Regulatory Affairs , Tactical Implementation, on the ...CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure… more
- Unknown (Boston, MA)
- … CMC development programs. The ideal candidate will have a strong background in Regulatory Affairs CMC , with experience leading regulatory strategies ... guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes in regulations… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …and commercial strategy.Collaborate closely with internal functions such as Pharmacology, CMC , Regulatory Affairs , Clinical, and Program Management.Maintain ... an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Insmed Incorporated (NJ)
- …timelines, submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs , CMC , Clinical, Quality) to facilitate ... what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing,… more
- Astellas Pharma (Northbrook, IL)
- …in remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the ... (PhD, PharmD, MS preferred). + 10+ years of direct experience in CMC Regulatory Affairs within the pharmaceutical or biotech industry, with significant… more
- Taiho Oncology (Princeton, NJ)
- …Value Proposition: Join our dynamic and expanding mid-size company in the role of Director for Regulatory CMC directly reporting to Executive Director ... Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all...be required to perform other duties, as assigned. Job Details Job Family R&D Job Function Regulatory Affairs… more
- Boehringer Ingelheim (Athens, GA)
- …marketed product regulatory strategy in the Global Regulatory Affairs (RA) Chemistry, Manufacturing and Controls ( CMC ) function for pharmaceutical ... + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on... standards governing BIAH products and processes. + Represents regulatory affairs as a key leader during… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately ... **Overview** The Director , CMC provides leadership for the...Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA… more
