Manager, Regulatory Affairs

Generate Biomedicines•Somerville, MA

21h

About The Position

Generate:Biomedicines is seeking a proactive and experienced Regulatory Affairs Manager to lead and coordinate global regulatory activities for biologic therapeutics. This role involves independently managing key submission components, contributing to regulatory strategy, and ensuring compliance with global regulatory standards. The manager will work cross-functionally to influence the planning and execution of development programs, aligning them with evolving regulatory requirements. The ideal candidate should possess hands-on regulatory experience, strong technical and writing skills, and the ability to operate independently in a fast-paced, dynamic environment. The company is a clinical-stage generative biology company pioneering an AI revolution in drug design and development, focused on designing proteins with defined biological intent to reduce the uncertainty, time, and cost of developing protein-based medicines. Founded in 2018, Generate:Biomedicines is advancing a growing pipeline across multiple disease areas and protein modalities, unifying computational design and clinical development to shift towards systematic drug generation. The culture is grounded in scientific rigor, fearless curiosity, and inclusive collaboration, aiming to deliver better medicines to patients faster.

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.

Nice To Haves

Advanced degree preferred.
Experience with Veeva Vault RIM or similar regulatory systems preferred.
A collaborative, curious, and solutions-focused mindset.

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.