Senior Regulatory CMC Director — Biologics
Vor Bio
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. The candidate must be a proven leader with a track record in regulatory submissions for biologics, strong interaction with FDA sCDER, and ability to guide risk assessment and submission planning in a fast-paced biotech #J-18808-Ljbffr Vor Bio
- 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...Senior
- 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...Senior
$242k - $313.5k
...patients - realizing a world where people with immune‑mediated diseases can live life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific and strategic regulatory leadership for all Chemistry, Manufacturing, and...SeniorLocal areaFlexible hours2 days per week- 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...Senior
- 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...Suggested
- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who are currently expanding and seeking an experienced Regulatory... ...to support the global development and registration of biologic products across all stages of the product lifecycle....Senior
$241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP), you will lead a dynamic team within the PO&T function, driving the regulatory strategy for biologics and ATMPs in Biogen’s portfolio. Your role encompasses global, regional...Full timeTemporary workLocal area- 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...Senior
$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... ...agencies. Extensive experience in the development of biologics and combination biologic/device products is a must....SeniorContract workWorldwideFlexible hours- Vertex Pharmaceuticals Incorporated is seeking an Associate Director of Chemistry Manufacturing Controls (CMC) to lead global regulatory strategies for biologics. You will author, review, and deliver high-quality regulatory submissions and serve as the primary CMC interface...
$166.4k - $249.6k
...DescriptionGeneral Summary:The Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies across investigational and commercial products focusing on biologics. This role is accountable for authoring, reviewing, and...Full timeSummer workRemote workFlexible hours2 days per week$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$163.5k - $281.6k
...Company is seeking a highly experienced and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory CMC strategies for our cutting... ...a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required...SeniorFor contractorsWork at officeFlexible hours- Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy... ...providing strategic recommendations to senior leadership Stay current with evolving global... ...(e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering...SeniorFor contractorsWork at office
$275k - $315k
...Therapeutics is seeking a strategic and experienced Senior Director of Regulatory Affairs to lead and execute US regulatory strategy for our biologics pipeline. Reporting to the VP, Regulatory... ...functional teams (Clinical, Nonclinical, CMC, Biostatistics, Clinical Operations,...SeniorFull timeTemporary workWork at officeLocal area3 days per week$220k - $290k
...the U.S. and are exploring regulatory pathways for Europe and Japan... ...short and long‑term plans. The Senior Director, Regulatory Affairs has... ...which supports product (drugs, biologics and devices) development,... ...development program. Guide CMC, nonclinical and clinical personnel...SeniorTemporary workFor contractorsWork at officeWeekday work- ...Instagram, X and YouTube. Job Description The Senior Manager Regulatory Affairs, Chemistry, Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients to deliver biologics products to patients, including mAb, ADC and...SeniorWork at officeLocal areaRemote work
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...regulatory objectives with clinical, CMC, safety and commercial strategies.Evidence... ...standing experience of overall drug/biologic development processes and strategies...SeniorHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible for developing... ...stakeholders.Serves as senior Regulatory CMC representative on... ...Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs,...Full timeSummer workRemote workFlexible hours2 days per week- UCB in Cambridge, MA is seeking a Senior Principal Scientist to lead translational biology drug discovery with emphasis on muscle biology. You will shape in vitro and in vivo models and develop cellular and biochemical assays for early programs across multiple neuromuscular...Senior
$204k - $245k
...personal and we approach every challenge with radical care. The Director, Regulatory CMC is responsible for leading execution of global CMC... ...Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field) Minimum of 10–1...Full timeWork at officeFlexible hours3 days per week$238k - $374k
...knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for... ...submissions for small molecule and biologic products through Phase 2... ...Represents Global Regulatory Affairs CMC in senior-level governance and in interactions...Minimum wageTemporary workLocal areaRemote work- Voisin Consulting Life Sciences (VCLS) is seeking a Senior Director of US Regulatory Strategy to guide biotechnology and pharmaceutical clients through... ...strategy, particularly in the late-stage development of biologics, combination products, and gene therapies. The ideal...
- ...experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing... ...and commercialization of complex biologics, such as combination products, with... ...pathways, regulatory risk assessment, CMC, nonclinical and clinical...Senior
- ...Reference25-04484 The Global Regulatory Affairs (GRA) is responsible... ...Nonclinical / Clinical Associate Director will lead, conceive,... ...influence and negotiate with senior Nonclinical / Clinical leaders... ...including chemistry, molecular biology, or similar. PhD preferred, Masters...Senior
- GlaxoSmithKline is seeking a Senior Director, Early Phase CMC Medicine Research Leader to assure successful CMC delivery across Rx and Vx programs. You will coach, mentor and recruit CMC leaders, guiding projects from C2LO to Phase 3 and coordinating with EDLs, R&D and...Senior
- ...bring life‑changing therapies to patients worldwide. The Director, Regulatory Site CMC ensures efficient and compliant management of regulatory... ...Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile...Local areaWorldwide
$210k - $320k
...a highly talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio of in... ...secondary suppliers.Work directly with regulatory and key stakeholders on the... ...classification.Qualifications:BS/MS, Ph.D., in Biology, Chemistry, Chemical Engineering,...SeniorFull time$145k - $175k
...with serious diseases by unlocking biologically important targets long considered... ...? We are seeking a highly skilled Senior Manager/Associate Director, Regulatory Operations to support and help drive... ...Writing, Clinical Development, CMC, Quality, and external partners to...SeniorShift work- 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...
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