Director/Senior Director, Regulatory Affairs
4 weeks ago
Director / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality) Boston area (hybrid, flexible travel) Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below. A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program approaching BLA submission . This is a high-impact leadership role suited to someone who combines deep regulatory CMC expertise with the agility to work cross-functionally in a lean biotech setting. The Opportunity: You’ll be the CMC regulatory lead driving global submission strategy, from IND maintenance through BLA authoring and post-approval planning. You’ll partner closely with Manufacturing, Quality, and Supply Chain teams, shaping how the company engages with regulators across major markets. Key Responsibilities: Define and implement global CMC regulatory strategy for a late-stage biologic asset (Phase 3 → BLA). Lead preparation, authoring, and review of CMC sections for IND, BLA, and global submissions. Develop and execute the BLA roadmap, determining content strategy, data presentation, and agency engagement plans. Serve as the primary CMC regulatory point of contact with the FDA and other global agencies. Partner cross-functionally with Manufacturing, Quality, and Technical Operations to ensure regulatory alignment throughout process development, validation, and lifecycle management. Guide the organization on advanced modality expectations and best practices in biologics manufacturing. Contribute to future device strategy (auto-injectors, prefilled syringes, infusion/IV delivery systems), helping define regulatory pathways for combination products. Mentor and support junior regulatory professionals or cross-functional contributors, though this role is not directly managerial at present. What We’re Looking For: 10+ years of Regulatory Affairs experience , including direct CMC responsibility within biologics. Proven track record supporting late-stage submissions (Phase 3 - BLA) and global regulatory filings. Strong understanding of manufacturing and analytical CMC considerations for biologics. Ability to build and execute global regulatory strategies across the U.S., EU, and other key regions. Experience in advanced modalities or drug–device combinations highly preferred. Collaborative communicator who can influence senior stakeholders while remaining detail-focused. U.S.-based, with ability to travel to the Boston area a few times per quarter. Why Join: Opportunity to own regulatory strategy for a pivotal Phase 3 biologic asset. Work within a nimble, science-driven biotech backed by strong scientific and operational teams. Operate with autonomy and visibility across the full product lifecycle, from late clinical stage through potential licensure. Reach out directly for a confidential discussion: joel.isaac@vividresourcing.com | +1 (980) 222 2267
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Director/Senior Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality) Boston area (hybrid, flexible travel) A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program...
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Director/Senior Director, Regulatory Affairs
4 weeks ago
Boston, MA, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality) Boston area (hybrid, flexible travel) A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program...
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Director/Senior Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality)Boston area (hybrid, flexible travel)A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program...
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Director/Senior Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality)Boston area (hybrid, flexible travel)A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program...
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Director/Senior Director, Regulatory Affairs
6 days ago
Boston, MA, United States Vivid Resourcing Full timeDirector / Senior Director, Regulatory Affairs - CMC (Biologics | Phase 3 Asset | Advanced Modality)Boston area (hybrid, flexible travel)A clinical-stage biotech developing an advanced biologic therapy in Phase 3 is seeking a Director/Senior Director of Regulatory Affairs, CMC to lead regulatory strategy and execution for a pivotal autoimmune program...
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Senior Director, Global Regulatory Strategy Lead
4 weeks ago
Boston, MA, United States Olema Oncology Full timeOlema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the...
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Associate Director Regulatory Affairs
3 days ago
Boston, MA, United States Real Staffing Full timeJob ** Associate Director, Regulatory Affairs (Contract) Remote or Hybrid Contract * 6-12 months (with potential extension) About the * We are seeking an experienced Associate Director of Regulatory Affairs to join our team on a contract basis. This role will support regulatory strategy and execution across development programs, ensuring compliance with...
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Executive Director, Regulatory Affairs
6 days ago
Boston, MA, United States Vivid Resourcing Full timeJob Title: Executive Director, Regulatory Affairs (Consultant) Location: Boston Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect. Industry: Biotech / Pharmaceutical Innovation Type: Remote About the Opportunity We are seeking a distinguished Executive Director–level Regulatory Affairs...
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Executive Director, Regulatory Affairs
2 weeks ago
Boston, MA, United States Vivid Resourcing Full timeJob Title: Executive Director, Regulatory Affairs (Consultant) Location: Boston Find out more about this role by reading the information below, then apply to be considered. Industry: Biotech / Pharmaceutical Innovation Type: Remote About the Opportunity We are seeking a distinguished Executive Director–level Regulatory Affairs Consultant to partner with...
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Boston, MA, United States Olema Oncology Full timeOverview Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral...
