Regulatory CMC Lead Global Submissions & Strategy
$159k - $195kDyne Tx
A leading biotechnology firm in Waltham, MA is seeking an Associate Director of Regulatory Chemistry Manufacturing and Control (CMC). This role involves executing global regulatory strategies and partnering with various teams to support clinical registration and commercial development. Candidates should have a bachelor's degree in life science, 7+ years in biotech, and significant regulatory affairs experience. Annual compensation ranges from $159,000 to $195,000 USD, reflecting the company's commitment to competitive and fair pay. #J-18808-Ljbffr
$177k - $278.08k
...JobRx, Inc. is seeking a Regulatory Affairs professional in Boston, MA to manage regulatory CMC strategy for pharmaceutical products. The role requires 10+ years of experience with a strong focus on leading major submissions and ensuring regulatory compliance. This position...Regulatory- ...Scorpion Therapeutics in Cambridge, Massachusetts is seeking a leader in Global Regulatory Affairs CMC to oversee regulatory strategy and submissions for small molecules and biologics. The ideal candidate should have over 20 years of experience in the industry and a strong...Regulatory
$148.5k - $214.5k
...Mass Digital Health is seeking a Regulatory Affairs CMC Project Lead to guide cross-functional... ...of 6+ years of CMC regulatory strategy experience, you will coordinate regulatory submissions, mentor team members, and navigate complex global requirements. This role offers...Regulatory$137k - $215.27k
...for a professional in Boston, MA, to contribute to Global Regulatory Affairs CMC. The role requires 6+ years of regulatory CMC or Device... .... Responsibilities include executing regulatory strategies and managing submissions. The position offers a hybrid work model, with a...Regulatory$196k - $240k
...A biotechnology firm in Waltham, MA, is seeking a Director of Regulatory Affairs – CMC. This strategic role includes leading global regulatory strategies and mentoring team members. Candidates should have 10+ years of experience in biotech/pharmaceutical industries and...Regulatory$153.6k - $241.34k
...A leading pharmaceutical company is seeking an Associate Director to define and lead global regulatory strategies. This role requires significant experience in regulatory affairs and offers opportunities for strategic leadership across multiple projects. Located in Boston...Regulatory$196.8k - $295.2k
...Vertex Pharmaceuticals Inc (US) is seeking a Regulatory Strategy Director in Boston, MA. In this role, you will lead the development and implementation of global regulatory strategies for assigned projects. The successful candidate will have a Bachelor's degree in Biology...Regulatory- Sanofi is seeking a Global Submission Lead to manage regulatory submission activities for new global products. The role involves project management, ensuring compliance with regulatory standards, and leading cross-functional teams in a dynamic environment. The ideal candidate...Regulatory
- ...Digital Health is seeking a Senior Regulatory Affairs Specialist in Waltham... .... In this role, you will lead the regulatory efforts for... ...Medical Device (SaMD) across global markets, guiding product teams... ...affairs, especially with FDA submissions. The position offers a competitive...Regulatory
- ...A leading biopharmaceutical company is seeking a Director of Regulatory CMC in Boston, MA. This key role involves managing post-approval... ..., ensuring compliance with global regulations, and leading... ...partners while driving innovative regulatory strategies. #J-18808-Ljbffr...Regulatory
- Job title: Global Regulatory Strategist Location: Morristown,... ...developing regulatory product strategies for the oncology therapeutic area, leading regulatory efforts in... ..., clinical, CMC, commercial, and other... ...as needed Regulatory Submissions & Operations Leads submission...RegulatoryLocal area
$270k - $330k
...Ipsen Biopharmaceuticals Inc. is looking for a Senior Director of Global Regulatory Affairs specializing in Oncology. This critical role demands extensive regulatory leadership to manage programs, ensuring compliance and strategic alignment with global development objectives...Regulatory- ...Health company, is the leading clinical‑stage... ...founding team includes globally recognized medical innovators... ...integrated program strategy and coordinate... ...Clinical Operations, Regulatory, CMC, PK/PD, Safety, Medical... ...regulatory documents and submissions, including INDs, NDAs...Regulatory
- ...Global Submission Lead As Global Submission Lead within our R&D team, you will be responsible... ...planning, coordination, and tracking of regulatory priority portfolio and integration... ...companies for implementation of e-submission strategies between two companies. Ensure that...RegulatoryWorldwideFlexible hours
- Global Submission Lead Location: Morristown, NJ / Cambridge, MA. About the role As Global Submission... ..., coordination, and tracking of regulatory Priority portfolio and Integration submission... ...companies for e‑Submission strategies. Coordinate with Regulatory Operations...RegulatoryWorldwide
$238k - $374k
...JobRx, Inc. is seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate will provide... ...strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and working...Regulatory- ...A leading biopharmaceutical company is seeking an Associate Director for Global Regulatory Affairs in Boston. This role involves leading regulatory strategies for complex projects, ensuring compliance with global regulations, and serving as the primary FDA contact. The...Regulatory
- ...Takeda in Boston is looking for a GRA CMC Product Lead to oversee regulatory CMC strategies and lead submissions for investigational, registration, and post-approval processes. This role requires a strong background in biopharmaceuticals with 10+ years in the industry...Regulatory
$160k - $196k
...Associate Director, Regulatory Operations Global Submission Management page is loaded## Associate... ...by our shared purpose: leading the fight against MASH.... ...strengthening our workforce strategy to ensure we have the... ...including Regulatory Strategy, CMC, Clinical, Labeling, and...RegulatoryMinimum wageFull timeLocal areaRemote workFlexible hours- ...biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at... ...drugs, and a strong understanding of CMC requirements. Key responsibilities include managing...Regulatory
$142.73k - $237.88k
...GlaxoSmithKline in Waltham, MA is seeking a Device Lead for Global MSAT Drug Delivery and Aseptic Technology. This role emphasizes leading... .... The ideal candidate should have extensive experience in regulatory compliance, project management, and cross-functional leadership...Regulatory$160k - $196k
...A biopharmaceutical company is seeking an Associate Director of Regulatory Operations to lead regulatory submissions. The role requires collaboration across teams to ensure compliance and excellence, with responsibilities including planning complex submissions and maintaining...RegulatoryFlexible hours- ...seeking a seasoned professional for a role in Global Regulatory Affairs, focusing on Chemistry Manufacturing & Controls. The successful candidate will lead the development of regulatory CMC strategies and manage submissions critical to product lifecycle. Applicants must...Regulatory
- ...Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...Regulatory
- ...and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...and executing regulatory strategies that support global product... ...background is preferred. CMC experience is a plus.... ...Lead the preparation, submission, and maintenance of regulatory...Regulatory
- A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in... ...candidate will prepare regulatory submissions, interact with health... ...vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...Regulatory
- Initial Therapeutics, Inc. is seeking a CMC dossier leader to manage and coordinate CMC dossier preparation for regulatory submissions. This role demands strong knowledge in pharmaceutical development and experience in authoring CMC dossiers. You will work in Framingham...Regulatory
$148.5k - $214.5k
Sanofi is seeking a CMC dossier leader to manage the preparation and development processes within the... ...CMC Dossier Sciences team. This role focuses on leading cross-functional teams and ensuring timely regulatory submissions while leveraging digital tools and AI solutions....Regulatory$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...RegulatoryFlexible hours- Sanofi is seeking a Global Labeling Strategist to shape the development and implementation of global labeling strategies for products in clinical development. You will collaborate... ...with cross-functional teams, providing regulatory guidance and ensuring alignment between...Regulatory
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