Manager, Regulatory Affairs

The Role:

We are seeking a proactive and experienced Regulatory Affairs Manager to lead and coordinate global regulatory activities supporting the development of our biologic therapeutics. This role will independently manage key submission components contribute to regulatory strategy and help drive compliance with global regulatory standards. You will work cross-functionally to influence planning and execution of development programs helping ensure alignment with evolving regulatory requirements.

The ideal candidate brings hands-on regulatory experience strong technical and writing skills and the ability to operate independently in a fast-paced dynamic environment.

Heres how you will contribute:

• Independently lead the preparation and coordination of regulatory submissions (e.g. INDs CTAs amendments annual reports) including timeline and content planning.
• Act as primary author for select regulatory sections and submission documents.
• Coordinate and draft responses to health authority queries in collaboration with cross-functional teams.
• Represent Regulatory Affairs at cross-functional meetings and contribute to program development discussions.
• Interpret evolving regulatory guidance to inform program-level planning and ensure compliance.
• Collaborate across clinical CMC nonclinical and quality functions to ensure consistency and completeness of regulatory content.
• Maintain submission records and correspondence in the Veeva RIM system and ensure version control.
• Contribute to the development of briefing books and meeting materials for agency interactions.
• Provide logistical and strategic support for regulatory agency meetings and internal preparation sessions.
• Drive continuous improvement of submission processes including templates and best practices.
• Mentor junior regulatory staff and support onboarding initiatives.

The Ideal Candidate will have:

• Bachelors degree in a scientific discipline (required); advanced degree preferred.
• 35 years of regulatory affairs experience in the biotechnology/pharmaceutical industry preferably with biologics.
• Strong working knowledge of US and/or EU regulatory requirements.
• Demonstrated experience leading submission efforts and drafting key regulatory documents.
• Excellent organizational communication and technical writing skills.
• Ability to manage multiple priorities in a dynamic deadline-driven environment.
• Familiarity with eCTD publishing and electronic submissions.
• Experience with Veeva Vault RIM or similar regulatory systems preferred.
• A collaborative curious and solutions-focused mindset.

Who Will Love This Job:

At Generate:Biomedicines youll help shape a new era in biomedicine. Our culture is grounded in scientific rigor fearless curiosity and inclusive collaboration. Your work will directly support innovative research and regulatory excellence while advancing medicines for patients who need them most.

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 creationone 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 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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