Director, Regulatory Affairs CMC

Generate Biomedicines•Somerville, MA

6d•Hybrid

About The Position

About Generate:Biomedicines Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development. We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us! Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees. The Role We are seeking an experienced and forward-thinking Director, Regulatory Affairs to lead global regulatory strategy and execution across both CMC and clinical development programs. This individual will serve as the strategic interface between Regulatory Affairs, Technical Operations, Quality, Clinical, and Nonclinical functions—from early development through Phase 3 and registration. The ideal candidate brings a deep understanding of global CMC regulatory requirements, hands-on experience leading Health Authority interactions, and a proven ability to navigate complex global submissions. This role requires both strategic vision and operational excellence to support Generate’s rapidly advancing pipeline of biologic therapeutics.

Requirements

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; advanced degree (MS, PhD, or PharmD) preferred.

Nice To Haves

Experience working in a fast-paced, innovative organization with complex biologics or novel modalities preferred.

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.