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Generate:Biomedicines · 5 days ago

Director, Regulatory Affairs CMC

Somerville, MA

Full-time

Hybrid

Director/Executive

$186K/yr - $279K/yr

10+ years exp

Generate:Biomedicines is a therapeutics company pioneering Generative Biology™ to create breakthrough medicines. The Director, Regulatory Affairs will lead global regulatory strategy and execution across CMC and clinical development programs, ensuring compliance and timely submissions for biologic therapeutics.

Artificial Intelligence (AI)BiotechnologyHealth CareMedicalProduct Research

Responsibilities

Provide strategic Regulatory CMC leadership across Generate’s biologics portfolio, ensuring cohesive, phase-appropriate global strategies that support late-stage (Phase 3) development, registration, and lifecycle management

Lead the planning, preparation, and execution of global CMC regulatory submissions—including INDs, CTAs, BLAs, and MAAs—delivering timely, high-quality, and compliant documentation that meets global standards

Serve as the primary company representative for CMC-focused Health Authority interactions, leading strategy development, preparation of briefing materials, and direct engagement with agencies to clearly communicate company positions and achieve successful outcomes

Support global Phase 3 programs and registration activities by coordinating regional submissions, managing clinical and CMC amendments, and ensuring timely, high-quality responses to Health Authority queries

Partner closely with Technical Operations, Quality, and Supply Chain to integrate regulatory expectations into process development, analytical methods, quality systems, and supply-chain strategies across all stages of product development

Identify and communicate CMC-related regulatory risks and lead the development of proactive mitigation strategies in partnership with cross-functional stakeholders

Oversee submission readiness and post-submission activities, including management of regulatory commitments, agency correspondence, and follow-up actions

Stay current with evolving global CMC regulations and guidances, translating new requirements into practical internal strategies to maintain compliance and accelerate development

Provide regulatory input into clinical development plans, protocols, and study reports, ensuring strong integration between CMC, clinical, and nonclinical components to enable efficient global Phase 3 execution

Ensure compliance with internal SOPs and document-management procedures, and promote regulatory excellence by identifying opportunities to enhance documentation quality, submission efficiency, and cross-functional collaboration

Qualification

Regulatory CMC expertiseGlobal regulatory strategyHealth Authority interactionsBiologics manufacturing knowledgeECTD submission standardsRegulatory information systemsCommunication skillsLeadership skillsCross-functional collaborationProblem-solving skills

Required

10+ years of Regulatory Affairs experience in biotechnology or pharmaceutical industries, with significant expertise in Regulatory CMC and a solid understanding of clinical and nonclinical development

Proven experience supporting Phase 3 global development programs and registration submissions (IND, CTA, BLA, MAA) across multiple regions

Demonstrated success in leading CMC-related Health Authority meetings and interactions, including briefing package preparation, query management, and regulatory negotiations

Deep understanding of biologics manufacturing, analytical development, and quality systems within a regulatory framework

Strong knowledge of global regulatory requirements (FDA, EMA, MHRA, PMDA, and ICH) and experience applying them pragmatically to development programs

Familiarity with eCTD submission standards and regulatory information management systems (e.g., Veeva)

Excellent communication and leadership skills, with the ability to influence and drive decision-making in a cross-functional, matrixed environment

Bachelor's degree in a scientific discipline required