- Formation Bio (New York, NY)
- … documents, eg, INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings. Provides Regulatory CMC guidance around drug ... new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing… 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, ... Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee… 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...technical expertise, strategic thinking, leadership capabilities, and a strong regulatory and industry knowledge base in pharmaceutical sciences or… more
- Organon & Co. (Jersey City, NJ)
- …Reporting to the Director or Executive Director in Organon Regulatory Chemistry, Manufacturing and Controls ( CMC ), the Associate Principal Scientist is ... the product lifecycle. + Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC...and escalate potential regulatory issues to Organon Regulatory CMC management, as needed. **Required Education,… 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 ... thereafter coordinate patent and regulatory activities to deliver best-in-class IP positions. We expect this person to create and influence strategy, assist with… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …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)
- …maintenance, to ensure robust supply tracking and randomization supportCollaborate with CMC , Clinical Ops, Quality, Regulatory , and Commercial Supply teams ... 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… 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 ... Nonclinical, CMC ) to ensure effective coordination and execution of regulatory deliverables Monitor new regulations and guidelines to ensure internal processes… more
- Formation Bio (New York, NY)
- …from initial evaluation to pre-close. Coordinate cross-functional workstreams (Clinical, CMC , Regulatory , Nonclinical, QA, Commercial, Finance, Legal/IP). ... faster and more efficiently.About the PositionFormation Bio is seeking an Associate Director , Program Management - Asset Diligence & Integration to partner with our… more
- Insmed Incorporated (NJ)
- …what's possible for patients with serious diseases. Reporting to the Executive Director , Regulatory Operations, you'll be responsible for the publishing, ... submission trackers, and regulatory archives.Partner with cross-functional teams ( Regulatory Affairs, CMC , Clinical, Quality) to facilitate document… more
- Organon & Co. (Plymouth Meeting, PA)
- …Safety Assessment Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of strategy across the ... Additionally, cross-functional interactions with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs, chemistry, manufacturing and control ( CMC ), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...are sound, based on the most up-to-date literature and regulatory guidance and support the approved early development plans.… more
- Organon & Co. (Jersey City, NJ)
- …authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director , Biopharmaceutics will ... **Job Description** **The Position** The Associate Director , Biopharmaceutics will provide expert biopharmaceutical guidance on...to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other… 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 ... your skills. Position Summary: With minimal direction the incumbent manages the global regulatory CMC activities except Asia for all assigned Taiho Oncology… more
- Takeda Pharmaceuticals (Boston, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management ... requirements, beyond EU/US. who has an understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market… more
- Lilly (Philadelphia, PA)
- …determined 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… more
- BeOne Medicines (San Mateo, CA)
- …assigned projects. The individual will provide support to cross-functional teams on CMC regulatory strategies and process optimizations on relevant topics. ... **Essential Functions of the job:** + Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the… more
- Astellas Pharma (Northbrook, IL)
- …remote work are encouraged to apply. **Purpose and Scope:** We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United ... Affairs, Quality Assurance, Business Partners). Responsible for developing regional/global CMC regulatory strategy (eg, CMC strategy/planning for… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …and Controlslead for Xeris' commercial and clinical/late-stage products and projects. + Leads CMC Regulatory Submission support for US FDA and other Health ... **Overview** The Director , CMC provides leadership for the...of regulatory submissions. + Experience with complex CMC regulatory submissions for both development and… more
- Boehringer Ingelheim (Athens, GA)
- …with corporate goals. + Defines, plans, and oversees the development of high-quality CMC regulatory submissions, with a focus on securing timely approvals from ... expert evaluations of potential licensing opportunities, offering comprehensive global CMC regulatory assessments to support strategic business development… more
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