CMC Regulatory Strategy Director
BioSpace
Moderna is seeking a leader to manage a team of CMC experts in Norwood, MA, overseeing regulatory correspondence and applications, shaping product strategy, and guiding regulatory activities to produce high-quality CMC sections for submissions. You will lead interactions with health authorities, develop processes to support regulatory submissions, and ensure alignment with global guidelines across multiple therapeutic areas. Strong communication and strategic oversight are essential to success. #J-18808-Ljbffr BioSpace
$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...Suggested$142.5k - $256.5k
The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products,... ...will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the...SuggestedPermanent employmentWork at officeWork from home$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...Suggested- Takeda in Boston, MA seeks a Director of Regulatory Site CMC to lead post‑approval change management across multiple sites, guiding submissions and... ...regulatory activities. You will communicate regulatory strategy to drug development, registration, and post‑market teams,...Suggested
- Vertex Pharmaceuticals Inc is seeking a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies and submissions across small molecule programs. The role emphasizes strategic leadership, Health Authority...Suggested
- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory strategy for biologics assets from early development through BLA filing and post‑approval lifecycle management. You will collaborate with Process Development, Analytical...
- Beeline Medicines in Boston is seeking a Director, Regulatory Strategy - Global Regulatory Lead to shape integrated global regulatory plans for early... ...Phase II. You will collaborate with Clinical Development, CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA and...
$224.9k - $404.6k
...and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will be required to oversee the product strategy for all the products in their portfolio and lead...Permanent employmentFull timeWork at officeWork from home$186.23k - $279.35k
...passionate about science and experienced within regulatory affairs and drug development? Do you... ...get involved in the global regulatory strategies and support the research, development... ...the business. The Regulatory Affairs Director (RAD) provides strategic and...Hourly payFull timeTemporary workWorldwide3 days per week- Vor Bio seeks an exceptional and highly motivated Director/Sr Director Regulatory CMC to lead development and implementation of robust regulatory CMC strategies across programs and lifecycle stages to support telitacicept through clinical development and global registration...
- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for assigned programs. This individual contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality...
- Beeline Medicines Corporation is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead the CMC regulatory strategy for monoclonal antibodies and other large molecules. You will drive submissions, interact with FDA/EMA, and align cross‑functional teams across...
- Vertex is seeking an Associate Director of CMC to lead global regulatory strategies for biologics, author submissions, and interface with health authorities, leveraging AI-enabled tools to enhance document quality and efficiency. This role requires 8+ years in pharma/biotech...
- ...Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...
$150k
Premier Research is looking for a Regulatory Strategy, Director (Bay Area, Boston) to join our Regulatory Affairs team.You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and...Full time- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including monoclonal antibodies, from IND/CTA through BLA and post‑approval lifecycle. You will collaborate with Process Development, Analytical...
- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry,... ...manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...
- Flagship Pioneering in Boston seeks an Executive Director, CMC to lead CMC functions including Drug Substance Development and Regulatory CMC. The role requires a proven track record of driving CMC strategy across multiple programs, managing budget and risk, and ensuring...
- Rapport Therapeutics, located in Boston, is seeking an Associate Director of Regulatory Strategy to define regulatory paths for their small-molecule pipeline. This role offers meaningful ownership and the opportunity to influence development decisions within a collaborative...
- Voisin Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients through complex regulatory landscapes. This leadership role will focus on US FDA regulatory strategy, particularly in the late...
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...Remote jobPermanent employmentContract work
- AstraZeneca GmbH is seeking a Regulatory Affairs Director to provide strategic regulatory leadership within their Cardiovascular, Renal & Metabolism team. You will define and implement regulatory strategies for innovative medicines, engage with health authorities, and...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
- Vertex Pharmaceuticals Incorporated in Boston, MA, is seeking a Regulatory Strategy Associate Director to oversee the global regulatory strategy for development programs and marketed products. The ideal candidate will have a strong understanding of regulatory affairs frameworks...
- Beeline Medicines is seeking an Executive Director, Regulatory Affairs to lead global regulatory strategy for multiple programs. The role oversees IND/CTA/NDA/MAA submissions, health authority interactions, and lifecycle management. Hybrid work with on-site days is expected...
- A leading biotechnology company in Boston is seeking a Regulatory Strategy Senior Director to oversee global regulatory strategies for development programs. The role involves leading regulatory strategy development, ensuring cohesive integration of regulatory ideas, and...3 days per week
$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products throughout their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders, and manage multiple projects to support the...$168k - $252k
Job DescriptionGeneral Summary:The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in...Full timeSummer workRemote workFlexible hours2 days per week$190.4k - $285.6k
Job DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing and executing global regulatory strategies across multiple investigational and commercial products in the small molecule portfolio...Full timeSummer workRemote workFlexible hours2 days per week$163.5k - $281.6k
...invite you to join us. Eli Lilly and Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting-edge gene therapy portfolio. This role will be critical in shaping the regulatory...For contractorsWork at officeFlexible hours
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