Senior Director, Biologics CMC Regulatory Strategy
Beeline Medicines
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 Sciences, Quality, and external CMOs to ensure alignment with FDA/EMA expectations and global regulatory standards. As a senior leader, you will drive cross‑functional teams, influence regulatory decisions, and shape #J-18808-Ljbffr Beeline Medicines
$240k - $340k
...seeking an exceptional Head of Biology to lead the scientific strategy and execution that will... ...for VP level, or 7+ years for Senior Director level Drug-hunter track record... ...Ability to understand and use regulatory, clinical and CMC considerations to inform TPP,...SeniorRegulatoryFlexible hours$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...RegulatoryFull timeSummer workRemote workFlexible hours2 days per week- 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...SeniorRegulatory
- ...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... ...record in regulatory submissions for biologics, strong interaction with FDA sCDER, and...SeniorRegulatory
$235k - $285k
...Program Management and Portfolio Strategy Job TypeFull-... ...culture thrive. Join us as a Senior Director, CMC Technical Lead , and you’ll... ...teams, external partners, and regulatory authorities to ensure successful development of biologics on the Hypercon Platform. The...SeniorRegulatoryTemporary workLocal area- 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...Regulatory
$202.13k - $336.88k
...approach to R&DPosition Summary:As the Senior Director, Early Phase CMC Medicine Research Leader you will... ...acceleration, attrition-reduction strategies, and upper-quartile performance.... ...manufacturing, supply chain, quality and CMC regulatory strategy through leadership of the...SeniorRegulatoryFull timeLocal area$212k - $333.19k
...Industry: Pharmaceutical / Biotechnology A senior scientific leadership opportunity is... ...professional to lead discovery biology strategy within an AI-enabled research environment... ...Contribute to IND-enabling biology packages and regulatory development activities Monitor...SeniorRegulatoryTemporary work$242k - $313.5k
...mediated diseases can live life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific and strategic... ...developing and executing biologics CMC regulatory strategies from early clinical development through BLA filing...SeniorRegulatoryLocal areaFlexible hours2 days per week- 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...SeniorRegulatory
$173k - $285.33k
...outcomes. What You'll Do As a Director/Senior Director, CMC Drug Substance Development, you will... ...process development and manufacturing strategy to produce drug substances for GLP... ...and review drug substance sections of regulatory documents. You will: Lead Drug...SeniorRegulatory$210k - $290k
...highly collaborative Senior Director to lead Protein Analytics... ...readouts, synthetic biology, automation, microfluidics... ..., Biology, and CMC/Tech Ops, and translating... ..., aligning functional strategy with Generate's platform... ....Familiarity with regulatory expectations and analytical...SeniorRegulatoryShift work$195k - $330k
...How you’ll make an impact:Drive end-to-end CMC program management for mid to late-stage... ..., drug product, analytical, quality, regulatory, and supply chain workstreams.Support planning... ...15+ years (M.S.) of CMC experience; Sr. Director level requires commensurate additional...SeniorRegulatory$250k - $300k
...commercial product. As the Senior Director, Late-Stage Cell... ...robustness, quality and regulatory compliance. Lead... ...execute a comparability strategy for pivotal process changes... .... Author and review CMC sections of regulatory... ...of stem cell biology and 2D/3D stem cell expansion...SeniorRegulatory$150k - $211k
...SummaryReporting to the Director of Drug Substance (Biologics), MSAT, this role is an individual... ...management, and global regulatory submissions of complex... ...SMEs from MSAT, QA, QC, CMC, External Manufacturing,... ...lifecycle management strategies for assigned commercial products...RegulatoryTemporary workRemote workWorldwideFlexible hours$210k - $320k
...range of therapeutic editing strategies that Beam is using to... ...talented and motivated Sr. Director / Director of CMC, to lead our advancing portfolio... ....Work directly with regulatory and key stakeholders on the... ...Qualifications:BS/MS, Ph.D., in Biology, Chemistry, Chemical...SeniorRegulatoryFull time$275k - $300k
Senior Director, Toxicology (CNS Specialist) Centessa Pharmaceuticals... ...programs with strong biological validation. Our asset... ...‑level toxicology strategy from target selection... ...to global regulatory submissions. Key Responsibilities... ..., regulatory, and CMC to ensure toxicology...SeniorRegulatoryFull time- ...experienced and commercially minded Senior Director or Executive Director of US Regulatory Strategy to join our growing regulatory... ...commercialization of complex biologics, such as combination products, with... ..., regulatory risk assessment, CMC, nonclinical and clinical requirements...SeniorRegulatory
$170.9k - $231.3k
Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating global CMC regulatory strategies for development-stage programs. This role will... ...a broad scientific foundation in biologics and/or complex modalities, along...RegulatoryFull timeTemporary workWork at officeLocal areaFlexible hours$193.1k - $289.7k
...Description GENERAL SUMMARY The CMC Statistics Director (Scientific Fellow)... ...stability, quality control, and regulatory submissions. This... ...optimization, and control strategy development Develop and implement... ...statistical methodologies across biologics, cell and gene therapy,...RegulatorySummer workRemote workFlexible hours2 days per week- Regulatory Affairs CMC, Manager/Senior Manager Currently partnering with a public Biotech who are currently expanding... ...development and registration of biologic products across all stages of the... ...and implementing CMC regulatory strategies, to help with commercial readiness...SeniorRegulatory
$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston,... ...regulatory objectives with clinical, CMC, safety and commercial strategies.... ...experience of overall drug/biologic development processes and strategies...SeniorRegulatoryHourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week- ...develop & advocate strategic positions for CMC regulatory/CMC issues with cross functional... ...to our staff to develop robust product strategies that integrate CMC regulatory policy and... ...Education: Bachelor’s degree in pharmacy, biology, chemistry, Engineering or related...RegulatoryFull timeLocal area
- ...Associate Director, Regulatory Affairs CMC Founded over a decade ago, CRISPR Therapeutics is a leading... ...and implement innovative Regulatory strategies where little precedent exists. You will... ...in biochemistry, chemistry, biology, or related pharmaceutical fields including...RegulatoryContract workRemote work
$263k - $292k
...disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide... ...is seeking an experienced Senior Director, Biometrics to serve as the... ...development, dose-escalation strategy, interim analyses, regulatory...SeniorRegulatoryFull timeTemporary workInterim role- This is what you will do: The Senior Director, Rare Endocrinology and Rare... ...implementation of the PS strategy for four indications: Hypophosphatasia... ..., compliance, IT, legal, regulatory, training, medical, and... ...Rare disease/high-value biologics experience Date Posted09-Aug...SeniorRegulatoryFull timeWork at office
$166.5k - $264k
...Job Description Title: Director/Sr Director, Focused... ...to enhance delivery of biologics and gene therapies across... ....We are seeking a senior technical leader to define... ...and translational strategy for this platform at Lilly... ..., clinical, and regulatory stakeholders, and mentoring...SeniorRegulatoryFlexible hours$170k - $220k
Associate Director, Regulatory CMC - Solid Biosciences Charlestown, MA HQ Solid... ...development and regulatory strategy. We are seeking an... ...to strategic reviews with senior management. In addition to... ...pertaining to the CMC aspects of biological product development. Experience...RegulatoryFull timeTemporary workRemote workFlexible hours$240k - $389.4k
...patients.Purpose of the Role:The Senior/Executive Director [commensurate with... ...for the overarching medical strategy and medical oversight for multiple... ...on asset and disease biology) and applying this effectively... ...in the preparation of regulatory documents (IND, CTA, IMPD,...SeniorRegulatoryLocal areaRemote workFlexible hours- 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...Regulatory
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