CMC Regulatory Leader - Strategy & Submissions
Sionna Therapeutics
Sionna Therapeutics is seeking an experienced Regulatory Affairs leader to drive CMC regulatory strategy across its evolving clinical‑stage pipeline. The role requires coordinating global submissions, authoring CMC sections, and shaping regulatory strategy with QA, Clinical Drug Supply, and Regulatory teams. The ideal candidate will have 12+ years of regulatory leadership, strong scientific writing ability, and a proven track record with FDA/EMA submissions for small molecules, in a fast‑paced #J-18808-Ljbffr Sionna Therapeutics
- ...Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the U.S.... ...regulatory affairs mainly in the U.S., with a focus on IND and BLA submissions to the FDA. Experience as a liaison in the U.S. for FDA...RegulatoryLocal area
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Regulatory- ...Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory strategy and execution for innovative biologic... .... You will lead global regulatory submissions and collaborate with cross-functional teams...Regulatory
$148.5k - $214.5k
...Job title : CMC dossier leader ~ Location: Framingham, MA About the job Are you... ...the preparation of CMC dossiers for regulatory submissions to enable advancement of company’s product... ...Drive alignment between dossier strategy and CMC activities as a core CMC...Regulatory- ...Therapeutics is seeking an Associate Director for Technical Operations CMC Strategy to oversee the execution of CMC strategy across a diverse... ...experience in CMC strategy, ensuring alignment with Quality, Regulatory, Clinical, and Supply Chain. Role involves leadership in...RegulatoryRemote work
- Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and aligning with global regulatory... ...activities. You will communicate regulatory strategy to drug development, registration, and...Regulatory
- Job Title: CMC Demand & Supply Leader Location: Framingham, MA About the Job... ...Leader is to integrate Project Strategy, Clinical and CMC... ...of Projects in respect to Regulatory and Quality requirements.... ...DMPK, PCS) and Regulator submission/approval plans. Run forecast...Regulatory
- ...Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory...Regulatory
- ...Cambridge, Massachusetts is seeking a Regulatory Affairs Manager to lead the Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for vaccines. This role requires expertise... ..., and experience with regulatory submissions. The ideal candidate will possess a bachelor...Regulatory
- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...Regulatory
- ...Oncology is looking for a Senior Director of Regulatory Affairs based in Boston, MA. This role... ...of the global regulatory strategy for investigational products, ensuring... ...guide other departments in application submissions. The ideal candidate will have an advanced...Regulatory
$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...Regulatory$293k - $358k
...looking for a Vice President of Technical Operations to lead CMC strategy. This strategic role involves building a high-performing Technical... ...in small molecule drug development and will collaborate with Regulatory Affairs and Quality Teams to ensure successful delivery of...Regulatory$212k - $333.19k
...role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device... ...product regulatory strategies, particularly pertaining... ...serves as a key opinion leader and resource within Takeda... ...aspects of global regulatory submissions (e.g., Core Dossiers, INDs...RegulatoryFull timeTemporary workLocal areaWorldwideNight shift$218.4k - $327.6k
...BSMO at the GKD Disease Strategy Team (DST). The incumbent... ..., Quality, Supply Chain, Regulatory, Finance, and other relevant... ...of the GKD DST, this leader will partner cross‑functionally... ...compliance. Support CMC regulatory strategy and submissions in partnership with Regulatory...RegulatoryRemote workFlexible hours2 days per week$211.5k - $258.5k
Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing... ...encompassing pre-IND planning, IND/CTA submission strategy, Phase I/II/III development... ...programs, ensuring alignment with clinical, CMC, and non-clinical development...RegulatoryLocal areaFlexible hours2 days per week- Senior Director, Program Leader, Corporate Strategy At Agios, we are fueled by connections to transform... ...execution from clinical development through regulatory approval, launch, and lifecycle... ...clinical development, regulatory strategy, CMC, medical affairs, and commercial...Regulatory3 days per week
$228k - $330k
Flagship Pioneering in Cambridge, MA is in search of an Executive Director or Vice President, CMC. This senior leadership role is crucial to driving portfolio-level CMC strategy across multiple programs, requiring a robust blend of scientific knowledge and operational...- A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA...Regulatory
$260k - $360k
Rhythm Pharmaceuticals Inc. is seeking a Vice President of Regulatory Affairs to lead its Global Regulatory Affairs organization from Boston... ...role involves managing diverse teams, executing regulatory strategies, and ensuring high-quality outcomes in a fast-paced...Regulatory- Zevra Therapeutics is seeking a VP, Head of Regulatory Affairs to lead global regulatory strategy and execution across our portfolio. This role requires extensive... ...rare disease sector, with a focus on driving major submissions and ensuring compliance. The ideal candidate will...Regulatory
- ...Technology Lead - Data and AI, to scale enterprise data and AI capabilities. This Director-level role will shape AI strategy and ensure compliance with regulatory standards. The ideal candidate has extensive experience in data and analytics, and advanced degrees are...Regulatory
- Medella Life is looking for a Director of Regulatory Affairs to spearhead regulatory strategy for rare disease programs in Cambridge, MA. This role involves leading regulatory submissions and acting as the primary interface with health authorities like the FDA. The ideal...Regulatory
- ...Pharmaceuticals is seeking an Executive Director for Global Trial Strategy & Operations in Cambridge, MA. This role involves strategic... ...Cardiovascular, CNS, or Hematology. A strong understanding of regulatory compliance is essential. #J-18808-Ljbffr Alnylam...Regulatory
- Vertex Pharmaceuticals Incorporated is seeking a Regulatory Strategy Senior Director in Boston, a hybrid role where you will oversee the development... ...strategies for various programs. The position requires a leader with at least 12 years of experience in regulatory affairs...Regulatory
- Vertex Pharmaceuticals Incorporated is looking for a Regulatory Strategy Director based in Boston. This role will lead the development and implementation of regulatory strategies for various projects, ensuring compliance and effective communication across teams. The ideal...Regulatory
- Vertex Pharmaceuticals in Boston is seeking a Regulatory Strategy Associate Director responsible for overseeing global and regional regulatory... ...development, and experience with major health authority submissions. This role offers the flexibility of a hybrid or on-site...Regulatory
- ...leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...products. The candidate will prepare regulatory submissions, interact with health authorities like the FDA, and ensure compliance...Regulatory
- ...a Non-clinical Safety Lead to provide scientific leadership in non-clinical safety across regulatory interactions and innovative programs. You will lead and communicate strategies supporting clinical development goals. The ideal candidate possesses a PhD in Toxicology or...Regulatory
- ...Therapeutics is seeking a Director of Regulatory Affairs to develop and execute global regulatory strategies for rare hematologic disorders. You will lead complex submissions, guide cross-functional teams,... ...a strong background in global CMC regulatory requirements,...Regulatory
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