Senior Associate, Regulatory Affairs

Role Summary

We are seeking a Senior Associate, Regulatory Affairs. This newly created role offers an opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly. You will have the opportunity to support the preparation and completion of documentation to support submissions to the FDA and to ex-US regulatory agencies. Additionally, you will be a data steward of regulatory information, working closely with Regulatory Operations.

Key Responsibilities

• Data steward of regulatory data in the RIM system (e.g., enter, update, and maintain), ensuring accuracy, completeness, and timeliness
• Create, archive, and maintain regulatory submissions, Health Authority correspondence, and Health Authority commitments within the RIM system, in accordance with internal standards
• Maintain submission trackers, timelines, track submission history and Health Authority commitments to ensure visibility into milestones
• Coordinate with cross-functional teams and Regulatory Operations to support US submission planning, compilation, and timely delivery of regulatory documentation
• Support preparation and organization of regulatory submission components (e.g., INDs, CTAs, amendments)
• Perform QC activities (including eCTD QC for US submissions, as appropriate) to ensure completeness, consistency, and technical readiness
• Support inspection readiness activities (e.g., TMF health checks, document completeness reviews)
• Support department meetings and cross-functional communication, including agenda development, coordination of materials, and documentation of outcomes

Ideal Candidate

• BS (or equivalent) in related scientific discipline
• 2+ years of experience working in the pharmaceutical/biotechnology industry (regulatory affairs experience preferred)
• Strong organizational skills, attention to detail, and ability to manage multiple tasks concurrently
• Strong written and verbal communication skills