- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the ... regulatory strategies for post-approval changes. This role will also lead CMC regulatory strategy development and implementation in coordination with… more
- Insmed Incorporated (NJ)
- …we're in. Are you?About the Role:This position is a key role that will provide regulatory CMC (RA CMC ) leadership and strategy to achieve regulatory ... and guidance documents for pre- and post-approval submissions. As needed, communicate regulatory CMC requirements to team members and advise of implications… more
- Organon & Co. (Plymouth Meeting, PA)
- **Job Description** **The Position?** Reporting to the Director in Organon Regulatory CMC ,?the Associate Principal Scientist is responsible for?developing ... for assigned products across the product lifecycle. + Identify,?communicate?and escalate?potential regulatory issues to Organon Regulatory CMC management,… more
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, ... of deviations, CAPAs, change controls, and protocols/reports.Collaborate cross-functionally with CMC team, Regulatory , Clinical Operations, and Program… more
- 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
- Insmed Incorporated (San Diego, CA)
- …each other, and for the future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the regulatory leader on ... therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams ( CMC ,...the regulatory lead on cross functional teams ( CMC , clinical and project teams)Ability and experience in the… more
- Organon & Co. (Plymouth Meeting, PA)
- …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
- Merck & Co. (Rahway, NJ)
- …process & connectivity between functions supporting pipeline (ie clinical development, CMC , supply chain, & human health), and balancing needs of patients ... (as a lead GCS Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines, strategies and… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... The candidate should be capable of leading a cross-functional CMC team and is expected to be adept in...tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting,… more
- Organon & Co. (Plymouth Meeting, PA)
- …standards. + Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities ... cross-functional development programs with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls… more
- Organon & Co. (Jersey City, NJ)
- …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
- Programmable Medicine Operatin (Redwood City, CA)
- …Author and review technical documents such as protocols, reports, risk assessments, and CMC sections of regulatory filings Ability to review master batch records ... our external contract manufacturing network while ensuring compliance with cGMP, regulatory requirements. This is an individual contributor, hands-on position. As… more
- Endo International (Horsham, PA)
- …we serve live their best life. **Job Description Summary** The Associate Director , Manufacturing Operations will provide leadership and management of operations at ... including Upstream Processing, Downstream Processing, and Manufacturing Support. The Associate Director is a member of the site leadership team and works… more
- BeOne Medicines (San Mateo, CA)
- …Clinical Development, Clinical Operations, Global Statistics & Data Science, Safety, Regulatory , CMC , Portfolio). + Hands-on experience with modern data ... As Director of R&D Data Enablement / Data Products,...chain. By collaborating with stakeholders across Research, Clinical, Safety, Regulatory , Portfolio & Project Management and other R&D functions,… more
- BeOne Medicines (Emeryville, CA)
- …**:** The Manager, Regulatory Compliance Programs reports to the Senior Director of Regulatory Compliance and is responsible for driving program-level ... provides compliance oversight and guidance across Regulatory Operations, Regulatory Affairs, Quality, Safety/Pharmacovigilance, Clinical, CMC , and … more
- CSL Behring (Waltham, MA)
- …connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC . -Applies the CSL Leadership Capabilities - Build Bridges, ... three days a week. You will report to the Executive Director Head Regulatory . **Position Description** **Summary** - Regulatory leaders who support… more
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