- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing the ... supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug development and manufacturing/supply processes Understands,… more
- Formation Bio (New York, NY)
- …where you will work closely with our business development, legal, clinical, CMC , and data/engineering teams to on-board products with strong IP potential, and ... Comfortable working cross functionally, including partnering with clinical and CMC teams to identify patentable innovations during development, collaborating with… more
- Formation Bio (New York, NY)
- …more efficiently.About the PositionFormation Bio is seeking a motivated, experienced Director , Formulation Development to join our dynamic team. This critical role ... will report to the VP, CMC and will be responsible for leading formulation development...of formulations for injection. Cross-Functional Collaboration: Partner with other CMC groups (analytical development, supply chain, etc) quality assurance,… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Director of Clinical Supply Chain Operations is responsible for leading global demand planning ... plans for production, packaging, distribution, and clinical supply budgeting. The Director provides strategic leadership for Clinical Supply Chain & Logistics… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …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 ... NJ. Role OverviewWe are seeking a highly experienced and strategic Senior Director of Toxicology to lead and oversee all nonclinical safety assessment activities… more
- Formation Bio (New York, NY)
- …faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our ... from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory, Nonclinical, QA, Commercial, Finance, Legal/IP). Maintain trackers,… more
- Organon & Co. (Plymouth Meeting, PA)
- …regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls ( CMC ), medical affairs and business development are critical to the ... product label reviews and updates, as appropriate. + Oversee collaborations with CMC to evaluate process manufacturing impurities and/or degradants and conduct risk… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for contributing and/or devising the clinical pharmacology ... The Clinical Pharmacology Lead will serve as the medical monitor and/or study director responsible for the execution (in conjunction with the TMED Operations Lead)… more
- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, the ... Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee the… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of ... the general medicines portfolio of products marketed worldwide. The Associate Director , Biopharmaceutics will also be responsible for contributing to and reviewing… more
- Organon & Co. (Jersey City, NJ)
- … Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is responsible for developing and implementing ... Regulatory Chemistry, Manufacturing & Controls ( CMC ) strategies for assigned small molecule or biological products in accordance with global regulations and… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Associate Director , Regulatory Affairs, Tactical Implementation, you'll have a critical role in ... across assigned programs and market. Under the guidance of the Associate Director , you will ensure high-quality, timely, and compliant preparation and delivery of… more
- Insmed Incorporated (NJ)
- …possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, management, and ... trackers, and regulatory archives.Partner with cross-functional teams (Regulatory Affairs, CMC , Clinical, Quality) to facilitate document authoring, review, approval,… more
- Insmed Incorporated (NJ)
- …expand what's possible for patients with serious diseases. Reporting to the Director , Supplier Relationship Management , you'll partner closely with Commercial and ... personnel and internal cross-functional stakeholders across disciplines of Manufacturing, CMC , Quality, Legal, Procurement and Finance. The ideal candidate would… more
- Emanate Health (Covina, CA)
- …STAR measures coding related functions. The coding specialist will work with the IPA Director , Health Plan, and MSO personnel on HCC and STAR measures related tasks. ... systems. Excellent customer service skills required. **c.Minimum License Requirement :** CMC , CCS, CPC, or COC required. Delivering world-class health care one… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Director , CMC provides leadership for the Chemistry, Manufacturing and Controls ( CMC ) function for Xeris' commercial and clinical/late-stage ... translates into skillful and competent application of knowledge to ensure the CMC function is in alignment with the Company's corporate and departmental goals.… more
- Lilly (Philadelphia, PA)
- …to make life better for people around the world. **Position Overview:** The Associate Director - CMC Regulatory will leverage CMC technical knowledge and ... regulatory science expertise to drive global regulatory CMC strategies for Lilly | Avid diagnostic radiopharmaceutical products. This includes the delivery of all… more
- Sanofi Group (Framingham, MA)
- **Job Title:** Associate Director - CMC BioDPDM **Location** : Framingham, MA As Associate Director within CMC BioDPDM, you'll have the opportunity to lead ... turn the impossible into possible for millions. The Associate Director role is a key leadership role in ...Director role is a key leadership role in CMC Biologics Drug Product Development and Manufacturing. You will… more
- Lilly (Indianapolis, IN)
- …determined to make life better for people around the world. **Job Summary** The Director /Senior Director , CMC , Drug Product Development will lead formulation ... CDMOs) with capabilities in drug product development and manufacturing + Author CMC sections of regulatory submissions (IND, CTA) related to drug product development… 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 , ... CMC . Your expertise will play a pivotal and visible role in advancing CMC strategy and submissions of developmental, life cycle and post approval projects in US,… more
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