Associate Director, Regulatory CMC, Biologics

$166.4k - $249.6k

Vertex Pharmaceuticals

Associate Director of Regulatory CMC for biologics who will lead global regulatory strategy, author and review CMC submissions for investigational and commercial products, and serve as the primary Health Authority interface. The role emphasizes integration of AI and digital tools to enhance regulatory document quality and efficiency.

Responsibilities

Lead preparation, review, and lifecycle management of CMC sections in global regulatory submissions
Develop and execute global CMC regulatory strategies for assigned biologic programs
Serve as primary CMC regulatory lead for Health Authority interactions and communications
Lead regulatory assessment of CMC changes, deviations, and investigations
Apply AI-enabled tools for document authoring, review, and consistency checks

Requirements

Bachelor's degree in Biology, Chemistry, Pharmacy, Regulatory Affairs, or related life science field
8+ years pharmaceutical or biotechnology industry experience focused on biologics
Advanced knowledge of global regulatory CMC requirements (FDA, EMA, ICH, Health Canada)
Experience leading CMC regulatory submissions and Health Authority interactions for biologics
Strategic thinking, problem-solving, and cross-functional team leadership abilities
Working knowledge of AI tools for regulatory document preparation and review
Experience with structured content, data-driven authoring, and digital submissions

Compensation: $166,400 - $249,600 base

Apply

Vacancy posted 22 days ago

Similar jobs that could be interesting for youBased on the Associate Director, Regulatory CMC, Biologics in Boston, MA vacancy

Associate Director, Regulatory CMC, Biologics
$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...
Suggested
Full time
Summer work
Remote work
Flexible hours
2 days per week
Vertex Pharmaceuticals
Boston, MA
3 days ago
Associate Director, Regulatory Affairs, CMC- Biologics
$170.9k - $231.3k
OverviewThe Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementing global CMC regulatory strategies for... ...Director will bring a broad scientific foundation in biologics and/or complex modalities, along with strong communication...
Suggested
Full time
Temporary work
Work at office
Local area
Flexible hours
Alnylam Pharmaceuticals
Cambridge, MA
1 day ago
Associate Director, Regulatory Affairs CMC
## Associate Director, Regulatory Affairs CMCApplyremote type: Site Basedlocations: South Boston, MAtime... ...therapies to patients. As the Regulatory CMC lead for these programs, you will... ...required in biochemistry, chemistry, biology, or related pharmaceutical fields including...
Suggested
Contract work
Remote work
CRISPR Therapeutics
Boston, MA
4 days ago
Associate Director/Director, CMC Regulatory
$143k - $233k
As part of the Pharmaceutical Development team, this position will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs. Your Role: With minimal supervision, accountable for developing and...
Suggested
Relay Therapeutics
Cambridge, MA
1 day ago
Associate Director, Global Regulatory Science, CMC
$142.5k - $256.5k
The RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal role will focus on preparing and overseeing... ...and/or analytical focus.8+ years of experience in Biologics focused Regulatory CMCMultidisciplinary focus on...
Suggested
Permanent employment
Full time
Work at office
Work from home
Moderna Therapeutics
Norwood, MA
4 days ago
Associate Director, Global Regulatory, CMC
$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, depending... ...’ll Need (Basic Qualifications)BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely...
Permanent employment
Full time
Work at office
Work from home
Moderna Therapeutics
Norwood, MA
2 days ago
Associate Director, Global Regulatory Affairs CMC
$154.4k - $242.55k
...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...
Minimum wage
Local area
Remote work
Worldwide
Takeda
Boston, MA
4 days ago
Head of Regulatory CMC - Biologics & Advanced Therapy Medicinal Products (ATMP)
$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... ...regulatory agencies.Active engagement in major industry associations, conferences and forums.Strong collaboration and...
Full time
Temporary work
Local area
Biogen Idec
Somerville, MA
3 days ago
Associate Director, Regulatory Affairs CMC
Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for leading regulatory CMC activities for Anagram’s portfolio of products... ...New Drug Applications/Amendments (INDs), Biologics License Applications (BLAs), Investigational Medicinal...
Anagram Therapeutics, Inc.
Natick, MA
3 days ago
Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness... ...and governance forumsKnowledge and Skills:Knowledge of regulatory requirements and inspection expectations globallyExperience...
Full time
Summer work
Remote work
Flexible hours
2 days per week
Vertex Pharmaceuticals
Boston, MA
1 day ago
Associate Director, AI/ML (Biologics)
$154.4k - $242.55k
...seeking an innovative and dynamic AI/ML Associate Director with a passion for leveraging AI/ML... ...bispecifics, ADCs, fusion proteins, and other biologics modalities to join our Large Molecule... ..., including Discovery Biology, CMC, and Program Leadership, contributing to...
Minimum wage
Local area
Worldwide
Takeda
Boston, MA
1 day ago
Senior Director/Director, Regulatory Affairs CMC
$210k - $320k
...suffering from serious diseases.Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality... ...strategies for novel products.Diverse experience including biologics in the cell therapy space, drugs, and international...
Full time
Shift work
3 days per week
1 day per week
Beam Therapeutics
Somerville, MA
5 days ago
Director, Regulatory Affairs CMC
$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... ...and Experience:Bachelor’s Degree in Chemistry, Biology, Pharmacy, Regulatory Affairs, Pharmaceutical...
Full time
Summer work
Remote work
Flexible hours
2 days per week
Vertex Pharmaceuticals
Boston, MA
5 days ago
Associate Director/Director, CMC Regulatory
...Relay Therapeutics seeks an experienced CMC regulatory professional to lead chemistry, manufacturing, and control strategy development and execution for investigational and commercial pharmaceutical programs. This role requires independent management of global regulatory...
Relay Therapeutics
Cambridge, MA
26 days ago
Associate Director, CMC Team Lead
$161.5k - $218.5k
OverviewThe Associate Director, Downstream, Emerging Modalities, is expected... ...transition by leading CMC team as necessary for the assigned... ..., Formulation Development, Regulatory, Technical Operations, Quality... ...acting as CMC team lead for biologics or complex/hybrid modalities...
Full time
Temporary work
Local area
Flexible hours
Alnylam Pharmaceuticals
Somerville, MA
1 day ago
Associate Director, Global Regulatory Lead, Oncology
$154.4k - $242.55k
...class and best-in-class therapies, including ADCs, complex biologics and small molecules. Our goal is to accelerate access... ...a lasting impact on patients worldwide.Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the global...
Minimum wage
Local area
Remote work
Worldwide
Takeda
Boston, MA
3 days ago
Associate Director, Regulatory Data Management & Intelligence
$142.5k - $256.5k
...radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management &... ...closely with Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, Digital, and...
Permanent employment
Full time
For contractors
Work at office
Work from home
Moderna Therapeutics
Somerville, MA
1 day ago
Associate Director, Separation Sciences, Biologics Analytical Development
$154.4k - $242.55k
...empower you to shine? Join us as an Associate Director, Separation Sciences, Biologics Analytical Development in our... ...ensure method robustness to support regulatory filings, commercialization, and lifecycle... ...and review analytical content for CMC documents and support global...
Minimum wage
Work at office
Local area
Remote work
Takeda
Lexington, MA
5 days ago
Director or Senior Director, Regulatory CMC
$195k - $330k
...inclusivity, so that our people are valued, seen, and heard.How you’ll make an impact:Lead the development and execution of global regulatory CMC strategies for degrader programs across all stages of development, from early-stage activities through late-stage development...
Kymera Therapeutics
Watertown, MA
5 days ago
Associate Director, CMC Technology Delivery
$172.2k - $233k
Overview:Alnylam is seeking an experienced leader to serve as Associate Director, CMC Technology Delivery to lead the digital enablement and... ...products from declaration of Development Candidate (DC) to regulatory filings for Investigational New Drug (IND) and New Drug...
Full time
Contract work
Temporary work
Local area
Flexible hours
3 days per week
Alnylam Pharmaceuticals
Cambridge, MA
1 day ago
Associate Director Global Regulatory Affairs
...Hi, Title: Associate Director Global Regulatory Affairs Location: Cambridge MA Hybrid position - 2 days onsite Duration: Long Term... ...strategy and lifecycle management, with a primary focus on biologics . The ideal candidate will have strong experience...
SoftPathTechnologies
Cambridge, MA
2 days ago
Associate Director, Regulatory Affairs
$170k - $195k
...medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable. The... ...What's the opportunity? We are seeking a highly skilled Associate Director, Regulatory Affairs to support and help drive regulatory success and...
Work experience placement
Shift work
Parabilis Medicines
Cambridge, MA
5 days ago
Associate Director/Director Regulatory Affairs
...Job Description Job Description Associate Director, Regulatory Affairs Location: Boston, MA (Hybrid... ...multidisciplinary teams including CMC, clinical, and nonclinical functions.... ...experience in Regulatory Affairs supporting biologics or pharmaceutical development....
Permanent employment
Full time
Stirling QR
Boston, MA
5 days ago
Associate Director Regulatory Liaison - Oncology
$129k - $203.1k
...Job Description The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic... ..., Manufacturing and Control (CMC) as well as other functional areas (e... ...or other related doctoral degree in biological science, chemistry or related discipline...
Full time
For contractors
Local area
Relocation
Visa sponsorship
Flexible hours
Shift work
Merck & Co.
Boston, MA
1 day ago
Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
$147.5k - $221.3k
...Vertex Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs... ...continuous improvement, and ensure regulatory readiness through audits, assessments,... ...health field ~8+ years of relevant CMC quality or compliance experience ~ Knowledge...
Vertex Pharmaceuticals
Boston, MA
22 days ago
Mfg Operations Associate Director - Biologics, Drug Substance
$160k - $240k
Job DescriptionGeneral Summary:The Associate Director, Technical Services is accountable for the technical execution of biologics drug substance manufacturing at external manufacturing partners. This role is responsible for ensuring processes are executed as intended and...
Full time
Summer work
Remote work
Flexible hours
Shift work
2 days per week
Vertex Pharmaceuticals
Boston, MA
4 days ago
Director, Regulatory CMC
$182k - $275k
...barriers, together. Opportunity Overview This role is responsible for executing high-quality, science-based, and compliant regulatory CMC deliverables for assigned program(s), in alignment with strategies established by Global Regulatory Affairs and Technical...
Full time
Work at office
Rhythm Pharmaceuticals
Boston, MA
more than 2 months ago
Associate Director, Medical Writing - Lead Regulatory Docs
...Inc.Posted: 2026-08-03Rhythm Pharmaceuticals Inc. in Boston is seeking an experienced Associate Director of Medical Writing to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle.You will partner with cross...
Rhythm Pharmaceuticals
Boston, MA
3 days ago
Director, Regulatory CMC
...Beam Therapeutics seeks a Senior Director or Director of Regulatory Affairs focused on Chemistry, Manufacturing, and Controls (CMC). This role leads regulatory strategy and CMC... ...gene therapy, cell therapy, or advanced biologics manufacturing requirements Demonstrated...
Beam Therapeutics
Cambridge, MA
20 days ago
Director, Regulatory Affairs CMC
$190.4k - $285.6k
...Director leading Chemistry Manufacturing Controls regulatory strategy for small molecule products at a global biotechnology company. Oversees CMC submissions, Health Authority interactions, and team development... ...'s degree in Chemistry, Biology, Pharmacy, Regulatory Affairs...
Vertex Pharmaceuticals
Boston, MA
22 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, Regulatory CMC, Biologics. Be the first to apply!