Director, Regulatory Affairs CMC

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 millionin 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 functionsfrom 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 Generates rapidly advancing pipeline of biologic therapeutics.

Heres how you will contribute

• Provide strategic Regulatory CMC leadership across Generates 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 submissionsincluding INDs CTAs BLAs and MAAsdelivering 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.
• Bachelors degree in a scientific discipline required; advanced degree (MS PhD or PharmD) preferred.

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

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 Companys 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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