Talent.com
Executive/Senior Director Regulatory CMC
Executive/Senior Director Regulatory CMCVivid Resourcing • Boston, MA, US
Executive / Senior Director Regulatory CMC

Executive / Senior Director Regulatory CMC

Vivid Resourcing • Boston, MA, US
[job_card.variable_hours_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

Job Description

Position Overview

Our client, an innovative and fast-growing biopharmaceutical company based in Boston, is seeking a Senior / Executive Director, Regulatory CMC to lead global Chemistry, Manufacturing & Controls (CMC) regulatory strategy across a dynamic development and commercial portfolio.

This leader will be responsible for designing and executing global CMC regulatory strategies, overseeing all CMC submissions, and leading key health authority interactions. The role requires deep scientific expertise, exceptional strategic judgement, and the ability to partner effectively across CMC, Technical Operations, Quality, Supply Chain, and Program Leadership.

This is a high-visibility, onsite leadership role with significant influence over technical development and regulatory direction.

Key Responsibilities

Strategic CMC Regulatory Leadership

  • Develop and own the global CMC regulatory strategy for assigned programs from early development through commercial lifecycle.
  • Provide expert guidance on CMC regulatory requirements, precedents, and evolving global expectations.
  • Ensure strategic alignment with corporate objectives, development plans, and commercialization goals.

Regulatory Execution & Submissions

  • Lead the preparation, authoring, and review of CMC modules (Module 3, Quality Overall Summary, regional requirements).
  • Oversee regulatory content for INDs / IMPDs, BLAs / NDAs / MAAs, supplements, variations, and global post-approval changes.
  • Drive regulatory risk assessments and propose mitigation strategies for technical and operational challenges.

    • Agency Engagement & Communications

  • Serve as a primary company representative in interactions with FDA, EMA, and other global authorities.
  • Strategically plan and lead key regulatory meetings, including Scientific Advice, Type B / C meetings, and pre-approval discussions.
  • Manage responses to health authority questions with scientific, high-quality, and timely communication.

    • Cross-Functional Integration

  • Collaborate closely with Process Development, Manufacturing, Quality Assurance, Analytical Development, Supply Chain, and Program Leadership.
  • Provide regulatory input into process changes, technology transfers, comparability, control strategies, and analytical plans.
  • Support inspection readiness and post-inspection regulatory follow-up where applicable.

    • Leadership & Team Development

  • Lead, mentor, and develop a team of Regulatory CMC professionals (Directors, Managers, Strategists).
  • Foster a culture of excellence, accountability, and proactive regulatory intelligence.
  • Establish best practices, operating procedures, and standards for high-quality regulatory deliverables.

    • Qualifications

    Education

  • Advanced degree preferred (Ph.D., Pharm.D., M.S.) in Chemistry, Pharmaceutical Sciences, Biochemistry, or related discipline.
  • Bachelor’s degree with extensive relevant experience will be considered.

    • Experience

  • 12–18 years of progressive experience in Regulatory CMC or CMC development within the biopharmaceutical industry.
  • 8+ years in leadership roles overseeing CMC regulatory strategy and submissions.
  • Demonstrated success leading major regulatory submissions (e.g., IND / IMPD, BLA / NDA, MAA).
  • Experience with complex modalities such as biologics, mRNA, cell / gene therapy, or viral vector products is strongly preferred.
  • Strong track record interacting with U.S. and global regulatory authorities.
  • Experience supporting commercial products and post-approval lifecycle management is a plus.

    • Skills & Competencies

  • Deep knowledge of global CMC regulatory requirements and ICH guidelines.
  • Ability to translate complex technical CMC content into clear regulatory strategies.
  • Strong leadership presence with the ability to influence across all levels.
  • Highly collaborative, solutions-oriented, and comfortable working in fast-paced, growing organizations.
  • Exceptional written and verbal communication skills.

    • Additional Details

  • Work Model : Onsite in Boston; executive presence and engagement with technical teams are essential.
  • Travel : Occasional domestic and international travel for agency meetings or partner engagements.
  • Compensation : Competitive senior-leadership package including salary, bonus, equity, and benefits.
    • [job_alerts.create_a_job]

    Director Regulatory Cmc • Boston, MA, US

    [internal_linking.similar_jobs]
    Director, Regulatory Site CMC

    Director, Regulatory Site CMC

    Takeda • Boston, MA, United States
    [job_card.full_time]
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Regulatory CMC (Remote)

    Director, Regulatory CMC (Remote)

    IMMUNEERING CORPORATION • Cambridge, MA, US
    [filters.remote]
    [job_card.full_time]
    About Immuneering : Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Ph...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, CMC (Drug Substance)

    Director, CMC (Drug Substance)

    Cedent Consulting • Boston, MA, United States
    [job_card.full_time]
    Reporting to the Vice President, CMC and QA, this role is key to progressing client’s programs to clinical development.The successful candidate will be a hands-on leader working cross-functionally ...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting Group, Inc. • Boston, MA, United States
    [job_card.full_time]
    Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively? Join...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Executive Director, Head, Global Regulatory Information, Data & Systems

    Executive Director, Head, Global Regulatory Information, Data & Systems

    Takeda Pharmaceutical Company Ltd • Boston, MA, United States
    [job_card.full_time]
    This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy.Head, Global Regulatory Operations (GRO). Head of Global Regulatory Information, Data and Systems (GRIDS) ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel CT Technologist

    Travel CT Technologist

    Medical Solutions Allied • Brockton, MA, US
    [job_card.full_time]
    Medical Solutions Allied is seeking a travel CT Technologist for a travel job in Brockton, Massachusetts.Job Description & Requirements. We’re seeking talented healthcare professionals who...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, CMC Regulatory Affairs

    Associate Director, CMC Regulatory Affairs

    Alkermes • Boston, MA, United States
    [job_card.full_time]
    Associate Director, CMC Regulatory Affairs.Associate Director, CMC Regulatory Affairs.Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Regulatory Strategy Consulting

    Senior Director, Regulatory Strategy Consulting

    Halloran Consulting Group • Boston, MA, United States
    [job_card.full_time]
    Career Opportunities with Halloran Consulting Group.Senior Director, Regulatory Strategy Consulting.Are you looking for a company that is committed to improving human health, and a role that will d...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Regulatory Affairs Director - Oncology

    Senior Regulatory Affairs Director - Oncology

    AstraZeneca • Boston, MA, United States
    [job_card.full_time]
    Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on!.At AstraZeneca,...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Executive Director, Specialty and Ambulatory Pharmacy Leader

    Executive Director, Specialty and Ambulatory Pharmacy Leader

    Boston Medical Center (BMC) • Boston, MA, United States
    [job_card.full_time]
    Executive Director, Specialty and Ambulatory Pharmacy Leader.Boston Medical Center Health System (BMCHS) is a $6 billion revenue integrated academic health care system whose purpose is to provide e...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Executive Director, Global Regulatory Operations (Boston, MA)

    Executive Director, Global Regulatory Operations (Boston, MA)

    BOSTON TRUST WALDEN COMPANY • Boston, MA, United States
    [job_card.full_time]
    The Executive Director, Regulatory Operations is responsible for leading the teams of publishing, submission management, regulatory information management, compliance and the regulatory management ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Senior Director, Regulatory Affairs

    Senior Director, Regulatory Affairs

    Formation Bio • Boston, MA, United States
    [job_card.full_time]
    Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.Advancements in AI and drug discovery are creating more candidate drugs than the ind...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Executive Director TMC Cancer Center

    Executive Director TMC Cancer Center

    Boston Staffing • Boston, MA, US
    [job_card.full_time]
    Executive Director Cancer Center.Tufts Medicine is an innovative, mission-driven health system that unites the best of academic and community medicine to deliver exceptional, connected, and accessi...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Associate Director, Regulatory CMC

    Associate Director, Regulatory CMC

    Solid Biosciences • Charlestown, MA, US
    [job_card.full_time]
    Associate Director, Regulatory CMC – Solid Biosciences.Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neu...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director / Senior Director, CMC, Drug Product Development

    Director / Senior Director, CMC, Drug Product Development

    Eli Lilly and • Boston, MA, United States
    [job_card.full_time]
    At Lilly, we unite caring with discovery to make life better for people around the world.We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Associate Director, Global Regulatory Lead, Oncology

    Associate Director, Global Regulatory Lead, Oncology

    Takeda Pharmaceutical (US) • Boston, MA, United States
    [job_card.full_time]
    By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Director / Vice President, Regulatory Affairs

    Senior Director / Vice President, Regulatory Affairs

    Korro Bio • Cambridge, MA, US
    [job_card.full_time]
    Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform.Korro is generatin...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director of Regulatory Affairs, CMC

    Director of Regulatory Affairs, CMC

    Blonde Inc. • Boston, MA, United States
    [job_card.full_time]
    Director of Regulatory Affairs, CMC.This role provides strategic leadership for all CMC-related regulatory activities—from early development through commercialization—ensuring high-quality submissi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]