Director, Regulatory Affairs CMC

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.

Here’s How You Will Contribute

• 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.

The Ideal Candidate Will Have

• 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.
• Experience working in a fast-paced, innovative organization with complex biologics or novel modalities preferred.
• Bachelor’s degree in a scientific discipline required; advanced degree (MS, PhD, or PharmD) preferred.

Location: Somerville, MA (Hybrid-onsite minimum 2-3 days per week

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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