Senior Director, CMC Regulatory Affairs (Small Molecules)
Doist
Beeline Medicines in the United States is seeking a Senior Director, Regulatory Affairs CMC – Small Molecules to lead regulatory strategy for all CMC activities across the immunology and inflammation portfolio. You will shape global regulatory submissions, oversee IND/CTA through NDA, and partner with Process Chemistry, Analytical Sciences, Quality, and external CMOs to ensure FDA/EMA alignment.
The role is hybrid with two on-site days weekly and requires strong leadership, HA interactions, and
#J-18808-Ljbffr$242k - $313.5k
...realizing a world where people with immune-mediated diseases can live life fully. Job Summary: The Senior Director, Regulatory Affairs CMC – Small Molecules provides senior-level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and...SeniorFull timeLocal areaFlexible hours2 days per week$265k - $285k
...approach has the potential to revolutionize the development of small molecule therapies. We are excited about the potential of our lead... ...Combine strategic leadership with hands‑on execution to shape Regulatory CMC strategy, advance our pipeline, and build the function for...SeniorFull timeWork at officeLocal areaImmediate start$200k - $220k
Director/ Senior Director, Regulatory CMC Join Us in Tackling Autoimmune Disease at Its Root At Vor, we believe science can do more than manage symptoms... ...of combination biologic/device products required. Small molecule and medical device experience are a plus. Experience...SeniorContract workWorldwideFlexible hours- Olema Oncology seeks an Associate Director GMP Quality to oversee GMP activities for... ...and commercial products, focusing on small molecule drug substances. You will review analytical... ...10-15% travel, the role partners with CMC, Regulatory, and Supply Chain teams to prepare...Senior
$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...products in the small molecule portfolio. This role... ....Serves as senior Regulatory CMC representative... ...Pharmacy, Regulatory Affairs, Pharmaceutical...SuggestedFull timeSummer workRemote workFlexible hours2 days per week$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking... ...regulatory strategies and submissions for small molecule and biologic products through... ...Global Regulatory Affairs CMC in senior-level governance and in...Minimum wageTemporary workLocal areaRemote work- Beeline Medicines is seeking a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets across the development... ...Health Authorities, advise on ICH guidelines for large molecules, and shape post‑approval change management and...Senior
$137k - $215.27k
...possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$275k - $315k
...seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy... ...and approval. You will manage a small team of Regulatory Affairs professionals... ...teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations,...SeniorFull timeTemporary workWork at officeLocal area3 days per week$137k - $215.27k
...A leading pharmaceutical company in Boston is seeking a Senior Staff Engineer to design and develop processes for small molecule active pharmaceutical ingredients. The ideal candidate will have a Ph.D. in Chemical Engineering with extensive industry experience. Responsibilities...Senior$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies... ...of global CMC regulatory strategies for innovative small molecules, biologics, and complex modalities across early- and...Full timeTemporary workWork at officeLocal areaFlexible hours$270k - $350k
The Senior Director, Regulatory Affairs is responsible for planning, developing, and implementing regulatory... ..., and compliance activities for small molecule programs across early and late-stage... ...implementation of clinical, nonclinical, and CMC regulatory strategy—including...SeniorShift work- ...Position Grade: The position level varies from Director to Sr. Director, determined by the... .... Must Haves: Prior experience in CMC-related business development or activities... ...Experience in business development within the small molecule sector of CDMO/Biotech & Biopharma...SeniorContract work
- Rhythm Pharmaceuticals, Inc. is seeking an experienced Regulatory CMC professional to execute high-quality, compliant CMC deliverables for... ...contributor role collaborates with Global Regulatory Affairs, Technical Operations, and Quality to ensure timely, complete...Senior
- Vertex Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities...
$145k - $215k
...industry-leading pipeline of oral small molecule degraders to provide a new generation... ...:Kymera Therapeutics is seeking a Senior Manager, Regulatory Affairs to serve as a key regulatory contributor... ...programs. Reporting to the Director of Regulatory Affairs, the Senior Manager...Senior$220k - $370k
...a highly motivated and experienced Senior Director or VP of Regulatory Affairs. The ideal candidate will have a proven... ...into clinical, nonclinical, CMC, quality, pharmacovigilance, medical... ...biotechnology or pharmaceutical company, small biotechnology experience is preferred...SeniorFull timeSummer workWork at officeFlexible hours$259k - $317k
...in the lives of patients we serve.Position Summary:The Senior Director of Regulatory Affairs is a senior leader responsible for developing and... ...plusExperience across multiple therapeutic areas or modalities (small molecule, biologics, gene therapy, combination products)...SeniorFull timeWork at officeFlexible hours$174.5k - $274.23k
...bring life‑changing therapies to patients worldwide. The Director Regulatory Site CMC ensures efficient and compliant management of regulatory... ...the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role...Minimum wageTemporary workLocal areaRemote workWorldwide- Vertex Pharmaceuticals Inc is seeking a Strategic Sourcing Manufacturing & Supply Director for Small Molecules at its Boston, MA headquarters. You will lead a team, partner with senior stakeholders, and drive sourcing strategy, CDMOs, and supplier governance across API...Work at officeRemote work
- ...Incorporated is seeking a Strategic Sourcing Manufacturing & Supply Director for Small Molecules in Boston, MA. This leadership role focuses on materials... ...strategies, manage key suppliers, and collaborate with senior leaders to deliver value, improved timelines, and cost...Work at officeRemote work
$207k - $253k
## Director, Regulatory Affairs CMCApplylocations: MA - Waltham - Officetime type: Full timeposted on:... ...tactical and operational regulatory CMC leadership to support clinical trial... ...commercialization and life cycle management of small molecule products.* Demonstrated experience...Minimum wageFull timeLocal areaFlexible hours$207k - $253k
...MASH). This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market... ...in clinical, commercialization and life‑cycle management of small‑molecule products. Demonstrated experience interacting with global Health...Full timeFlexible hours$212k - $333.19k
...push the boundaries of what is possible in order to bring life‑changing therapies to patients worldwide. As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you will provide leadership for the development and...SeniorMinimum wageFull timeTemporary workLocal areaWorldwideNight shift$194.1k - $305.6k
...next generation of our Company's Oncology small molecule therapeutics. Come join an incredible... .... Ensure compelling engagement with regulatory agencies. - ~ Lead business development... ...- ~ Experience managing a group of senior and junior scientists with a track...SeniorFull timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica... ...and aligning regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence and Decision-Making...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$212k - $333.19k
...conjugates (ADCs), complex biologics and small molecules. Our goal is to accelerate access... ...worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be... ...understanding broad concepts within regulatory affairs and implications across the...SeniorMinimum wageTemporary workLocal areaRemote workWorldwide$157k - $173k
...LinkedIn . Position Summary: The Senior Manager, Regulatory Affairs will support the development and... ...across nonclinical, clinical, CMC, and device components for Avalyn's development... ...preferred. Experience in a small biotechnology company or matrixed environment...SeniorFull timeLocal area- Senior Manager - Regulatory Affairs Operations Location - Cambridge, MA (Hybrid) Oncology Biotech | Global... ...submissions. The Role Reporting into the Director of Regulatory Affairs Operations,... ...with Regulatory Strategy, Clinical, CMC, and external partners to ensure...Senior
$257.03k - $311.46k
...-with-us.Bristol Myers Squibb (BMS) is seeking an experienced small molecule patent attorney or agent to join our research center in Cambridge... ...application should be directed to Chat with Ripley.R1604263 : Senior Counsel, Innovation Law - Patents #J-18808-Ljbffr Bristol-...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workPrivate practiceLive inWork at officeLocal areaRemote workFlexible hoursShift work
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