Director, Regulatory CMC — Global Biologics Submissions
Legend Biotech US
Legend Biotech US is seeking a Director, Regulatory CMC based in Somerset, NJ, to lead global CMC regulatory strategies for late-stage and post-approval programs within Regulatory Affairs. You will influence development and manufacturing strategies and serve as the primary Regulatory CMC representative on cross-functional teams. The role requires 10+ years in biotech/pharma with 7+ years in Regulatory CMC, and a strong CMC background, including life sciences expertise and CAR-T experience is a #J-18808-Ljbffr Legend Biotech US
- Travere Therapeutics is seeking a Director, Technical Operations (Biologics CMC Technical Writing) to lead the preparation of regulatory CMC documentation, including BLA submissions. You will drive the strategy with Regulatory Affairs and SMEs, delivering rigorous, regulator...Suggested
- Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ. The role leads global CMC regulatory strategies for late-stage development... ...cross-functional teams, coordinate submissions with Health Authorities, and drive...Suggested
$193.5k - $243.6k
PTC Therapeutics is a global commercial biopharmaceutical... ...Description Summary: The Director, Regulatory Affairs - CMC is responsible for leading... ...management of primarily biological products. The Director leads... ...dossier for regulatory submissions of the various stages (eg...SuggestedTemporary workWork at office$193.63k - $254.14k
Legend Biotech is a global biotechnology company dedicated to... ...Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory... ...CMC planning, preparation of submissions, and interaction with... ...CMC experience supporting biologics, cell and gene therapy. Direct...SuggestedPermanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...Therapeutics, Inc in New Jersey is seeking an Associate Director, Regulatory Affairs - CMC. This role involves leading global regulatory strategy for product development and... ...skills, and the ability to prepare regulatory submissions including INDs and NDAs. #J-18808-Ljbffr PTC...Suggested
- Legend Biotech in Somerset, NJ is seeking a Director, Regulatory CMC to lead global regulatory strategies across late-stage development and post-approval lifecycle for commercial products. You will provide strategic regulatory leadership to cross-functional teams, interact...
$189k - $246k
...Diego, USA- Remote Be a part of a global team that is inspired to make a... ...patients. Position Summary The Director, Technical Operations (Biologics CMC Technical Writing) is... ...Controls (CMC) documentation for regulatory submissions, including Biologics License Application...Contract workTemporary workWork experience placementRemote work- ...Senior Director, Biologics CMC (4 days onsite, 1 day remote) Position Summary Reporting to the... ..., analytical development, quality, regulatory CMC, and external manufacturing.... .... Demonstrated experience managing global CDMOs. Strong knowledge of ICH and...Full timeRemote work
- Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory CMC to lead global strategies for late-stage and post-approval lifecycle management... ...CMC representative on cross-functional teams, shaping submissions and regulatory strategies while mentoring junior staff...
- Legend Biotech in Somerset, NJ, is seeking a Director of Regulatory CMC to lead global regulatory strategies for late‑stage and post‑approval programs... ...interact with Health Authorities to ensure compliant submissions. The role requires an advanced life sciences degree and...
- Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will... ...deep knowledge of global regulations for biologics and cell therapies; oncology...
- MMS Holdings Inc. is a data-focused clinical research organization actively supporting regulatory submissions across global markets. We value accuracy, collaboration, and continuous improvement in a fast-paced environment. The role focuses on regulatory operations, eCTD...
- Job Title: Director, Regulatory Affairs, Pharmaceuticals Employment... ...ClinChoice is a global full-service CRO dedicated... ...documents and submissions in accordance with clients... ...with CBER and global biologics experience highly... ...including Development, CMC, Labeling, Promotion,...Permanent employment
- Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based... ...in Somerset, NJ. You will lead the global regulatory strategies, coordinate... ...excellent communication. Experience with biologics and CDx is a plus. #J-18808-Ljbffr BioSpace
- Vertex Pharmaceuticals LLC seeks a Regulatory CMC Manager to drive international CMC submissions and regulatory strategies for cell and gene therapy programs. You... ...guidelines, and supporting post-approval changes in a global setting. #J-18808-Ljbffr Vertex Pharmaceuticals...
- ...Primary Responsibilities The Director/Senior Director, Regulatory CMC (Chemistry, Manufacturing, and Controls... ...CMC. • Develop and lead global CMC regulatory strategies for investigational... ...products to ensure timely submissions and approvals. • Prepare, review...Remote workFlexible hours
- ...Description This position in Regulatory Affairs involves the ability... .../apply knowledge of global regulations governing pharmaceutical... ...accuracy of all regulatory submissions. Supervisory... ...architecture and timing of a Biologics Licensing Application (BLA)...Local areaRelocation package
- CG Oncology seeks a Senior Director of Quality Control to oversee product quality and regulatory compliance across bladder cancer therapies from clinical to commercial... ...quality strategy and ensure GxP adherence in a global, multi-site setting. Lead analytical and manufacturing...
$168.37k - $220.99k
Legend Biotech is a global biotechnology company dedicated to... ...Legend Biotech is seeking a Director, Regulatory Affairs as part of the... ...ensure timely and high‑quality submissions. The Director will also work... ...development, experience in biologics and cell therapies is...Permanent employmentFull timeTemporary workFor contractorsLocal areaWorldwideFlexible hours- ...models with a synthetic biology data engine, enabling... ...targets. Absci is a global company headquartered... ...YouTube. Absci believes regulatory and compliance is the... .... The level (Director vs. Senior Director) will... ...agency interactions, submissions, and inspections — representing...
- Eisai Inc. is seeking a Director of Global Labeling to lead the development and execution of global regulatory labeling strategies for US, EU, Growth, and Rest of World markets. You will oversee CCDS, US PIs, EU SmPCs, and country product information, while guiding a high...
- Miltenyi Biomedicine seeks a Director, Regulatory Affairs with a CMC focus to lead regulatory CMC activities for cell therapy programs across the US... ...product approvals. Responsibilities include leading CMC submissions, providing strategic guidance to cross-functional...
$170k - $190k
Senior Manager, Global Regulatory Affairs Labeling This range is provided by Planet Pharma. Your actual pay will be based on your skills and... ...governance committee) prior to internal approval and/or submission of labeling to health authorities. Independently recommends...Full timeWork experience placementLocal areaRemote work- ...We represent a global P+C carrier looking to hire a Global Compliance Director based in New York City. The role is responsible for the design, implementation,... ...Financial Crime Compliance Insurance & Investment Regulatory Compliance Data Protection, Privacy &...Full time
$190k - $220k
...make an immediate, measurable impact on a global scale, within an environment that... ...System which makes everything possible.The Director, Global Trade Compliance is responsible... ...customs valuation processes, and global regulatory compliance.This position reports to the...Full timeImmediate startRemote workWork from homeFlexible hours- VIVA seeks a Regulatory Affairs professional to coordinate global submissions, review technical data, and prepare documentation for regulatory authorities. The role supports project plans, maintains regulatory files, and collaborates with cross‑functional teams to ensure...Remote jobFlexible hours
$157.5k - $210k
...latest podcast, from Dreamers to Disruptors, and follow us at @Medidata.About the Team:The Senior Director, Global Compliance & Strategy sets the strategic direction for regulatory affairs and quality management system (QMS) functions across Medidata’s life sciences...Work at officeRemote workFlexible hoursShift work- ...Senior Director, Regulatory Affairs - Hybrid NYC Area Key Responsibilities Develop and execute... .... Lead and support preparation and submission of regulatory filings, including INDs,... .... Ensure compliance with FDA and global regulatory requirements while...Full time
- ...focused on developing global beauty brands that deliver... ...Role The Manager, Regulatory Affairs is responsible... ...closely with the Director of Regulatory Affairs,... ...regulatory documentation, submissions, testing activities,... ...Regulatory Affairs, Chemistry, Biology, Cosmetic Science, or...Full time
- ...Executive Director, Regulatory Strategy About the Company Clinical-stage biopharmaceutical company developing innovative, transformational... ...expanding the regulatory organization to support various global submissions. This is a unique opportunity to shape the team and its...
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