Associate Director, Regulatory CMC - Biologics (AI-Driven Submissions)
Vertex Pharmaceuticals
Vertex is a global biotechnology company seeking an Associate Director in CMC to lead global regulatory strategies for biologics, authoring and reviewing submissions, and serving as the primary CMC interface with Health Authorities. The role emphasizes AI-enabled regulatory document preparation and data integrity to improve efficiency and compliance. You will guide cross-functional teams across INDs/NDAs/BLAs, manage lifecycle of CMC sections, and drive advanced digital capabilities while #J-18808-Ljbffr Vertex Pharmaceuticals
Vacancy posted 4 days ago
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$166.4k - $249.6k
...Manufacturing Controls (CMC) Associate Director leads and executes global regulatory CMC strategies... ...focusing on biologics. This role is accountable... ...regulatory submissions, while serving as... ...digital and AI-enabled approaches... ...content and data-driven authoringAbility...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- 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
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Overview The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating... ...a broad scientific foundation in biologics and/or complex modalities, along... .... Experience with regulatory submissions and health authority interactions...SuggestedFull timeTemporary workWork at officeLocal areaFlexible hours- ...Reporting to the Head of Regulatory Affairs, you will... ...patients. As the Regulatory CMC lead for these... ...biochemistry, chemistry, biology, or related... ...accomplishments: ~ Associate Director: ~12+ Years of relevant... ...eCTD requirements for submission to US and ex-US regulatory...SuggestedContract workRemote work
CRISPR Therapeutics
Boston, MA3 days ago - Vertex Pharmaceuticals in Boston seeks a Director, CMC to lead global regulatory strategies for the small molecule portfolio, overseeing submissions and Health Authority interactions. The... ...Regulatory CMC staff, and champions AI-enabled capabilities to improve content...Suggested
$142.5k - $256.5k
The RoleThe Associate Director, Global Regulatory, CMC will be responsible for coordinating regulatory CMC activities... ...regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and... ...Qualifications)BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry,...Permanent employmentFull timeWork at officeWork from home$242k - $313.5k
...diseases can live life fully. Job Summary The Senior Director, Regulatory Affairs CMC - Biologics provides senior‑level scientific and strategic... ...preparation of biologics CMC sections of global regulatory submissions in ICH CTD format, including INDs/CTAs, BLAs, MAAs, supplements...Local areaFlexible hours2 days per week$154.4k - $242.55k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...enables the development of robust and accurate submissions.Develops constructive relationships with and proactively...Minimum wageTemporary workLocal areaRemote workWorldwide$142.5k - $256.5k
...industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory... ...Regulatory Operations, CMC, Labeling, Quality, Enterprise... ...Objectives, Regulatory Submissions, Health Authority... ...Moderna’s strategy for AI-enabled regulatory data...Permanent employmentFull timeFor contractorsWork at officeWork from home$150k - $211k
...headquartered in France, driven by commercial-stage... ...SummaryReporting to the Director of Drug Substance (Biologics), MSAT, this role is an... ...management, and global regulatory submissions of complex Biologics, monoclonal... ...SMEs from MSAT, QA, QC, CMC, External Manufacturing,...Temporary workRemote workWorldwideFlexible hours$142.5k - $256.5k
Role Overview The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one... ...regulatory strategies for global submissions (IND, CTA, BLA, MAA) and identify... ...Qualifications BS, MS, or PhD in Molecular Biology, Pharmaceutics, Chemistry,...- ...Associate Director of Regulatory Affairs CMC Hybrid Role The Associate Director of Regulatory Affairs CMC will support... ...for an emerging portfolio of biologics products. This position will oversee CMC Health Authority submissions, collaborating across the business and...
Accede Solutions Inc.
Lexington, MA4 days ago $241k - $332k
About This Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP... ...timely product approvals.Ensure submission readiness and regulatory compliance... ...Active engagement in major industry associations, conferences and forums.Strong collaboration...Full timeTemporary workLocal area$163.5k - $281.6k
...work worth doing. If you’re driven by purpose and ready to... ...and strategic Director/Senior Director, Regulatory CMC to lead and execute regulatory... ...BLA/MAA, and post-approval submissions.Lead and manage the preparation... ...Biochemistry, Molecular Biology, Chemistry, Pharmacy,...For contractorsWork at officeFlexible hours- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on global Regulatory CMC strategies for... .... The qualified candidate will define Regulatory CMC submission strategies and plan, construct, direct, write summaries...
Voyager Therapeutics, Inc.
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- 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...
$163.2k - $244.8k
## Associate Director, Global Submission ManagementApplylocations: Boston, MAtime... ...of global regulatory submissions across... ...Strategy, Regulatory CMC, Labeling, Publishing... ...technologies, including AI driven tools, and... ...into causal human biology, including APOL1-mediated...Summer workRemote workFlexible hours2 days per week- ...Job Description Associate Director, Regulatory Affairs Location:... ...in U.S. regulatory submissions. This is a strategic... ...multidisciplinary teams including CMC, clinical, and... ...Affairs supporting biologics or pharmaceutical... ...Collaborative, science-driven consulting culture...Permanent employmentFull time
Stirling QR
Boston, MA23 days ago $136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction... ...: Lead CMC regulatory strategy; guide... ...packages for IND/IMPD submissions. API/Drug... ...through clear, data-driven risk/benefit... ...IMPD filings for biologics, conjugates, or... ...data science, and AI to better predict...Hourly payTemporary workBoston, MA22 days ago$150k - $195k
...Position Summary The Associate Director, Technical Operations, Biologics Drug Substance... ...Operations, Quality, and Regulatory Affairs on... ...Application (BLA) submissions. Responsibilities... ...documentation supporting CMC sections of IND,... ...and Teamwork. Driven, intelligent, passionate...Contract workTemporary workRemote work$190.4k - $285.6k
...DescriptionGeneral Summary:The Director, Chemistry Manufacturing Controls (CMC) leads a Regulatory CMC team responsible... ...of digital and AI-enabled capabilities to... ...preparation, and submission execution.Key Duties and... ...Degree in Chemistry, Biology, Pharmacy, Regulatory...Full timeSummer workRemote workFlexible hours2 days per week$168k - $252k
...Description General Summary The Regulatory Strategy Associate Director will be responsible for... ...process for preparation, submission, and approval of... ...technologies, including AI-driven tools, and maintains a continuous... ...Bachelor's degree in biology, Chemistry, or other related...Summer workRemote workFlexible hours2 days per weekVertex Pharmaceuticals
Boston, MA2 days ago$190k - $215k
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...Position Summary The Associate Director of MSAT (... ...commercial manufacturing of biologic drug substances and drug... ...sections of regulatory filings (BLA/MAA, responses... ...biologics PPQ and BLA/MAA submissions. ~ Expertise in... ...digital medicine. Driven by our purpose to defy...Full timeContract workTemporary workLocal areaRemote workWorldwideFlexible hoursOtsuka America Pharmaceutical Inc.
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$238k - $374k
...best of my knowledge.Job DescriptionExecutive Director, Global Regulatory Affairs CMC Early DevelopmentAre you looking for a patient... ...compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development. You will...Minimum wageTemporary workLocal areaRemote work- Vertex Pharmaceuticals Incorporated seeks a Chemistry Manufacturing Controls Manager to oversee regulatory CMC submissions and strategic interactions with agencies. You will partner with development and manufacturing teams to shape global CMC strategies for investigational...Remote work
$204k - $245k
...Director, Regulatory CMC Somerville, MA At Genetix Biotherapeutics every role has meaning, every... ...key role in supporting post-approval submissions, inspection readiness, and ongoing... ...life sciences (biochemistry, chemistry, biology, biochemical engineering, or related...Full timeWork at officeFlexible hours3 days per weekGenetix Biotherapeutics
Somerville, MA20 hours ago
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