Manager, Regulatory Affairs

Generate Biomedicines•Somerville, MA

About The Position

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. Generate:Biomedicines is a clinical-stage generative biology company pioneering the AI revolution in drug design and development. They 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, they 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, they translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation. At Generate:Biomedicines, they collaborate across disciplines in new ways to invent and innovate, bringing diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by their values and leadership behaviors.

Requirements

Bachelor’s degree in a scientific discipline (required)
3–5+ 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.
A collaborative, curious, and solutions-focused mindset.

Nice To Haves

advanced degree preferred
Experience with Veeva Vault RIM or similar regulatory systems preferred.

Responsibilities

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.