Manager, Regulatory Affairs

📋 Description

• Lead regulatory submissions (INDs, CTAs, amendments, annual reports) with timelines.
• Act as primary author for selected regulatory sections and submission documents.
• Coordinate and draft responses to health authority queries with cross-functional teams.
• Represent Regulatory Affairs at cross-functional meetings and contribute to program discussions.
• Interpret evolving regulatory guidance to inform program planning and ensure compliance.
• Collaborate across clinical, CMC, nonclinical, and quality teams to ensure completeness of regulatory content.

🎯 Requirements

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• 3-5+ years regulatory affairs experience in biotech/pharma, preferably with biologics.
• Strong working knowledge of US and/or EU regulatory requirements.
• Demonstrated experience leading submission efforts and drafting key regulatory documents.
• Familiarity with eCTD publishing and electronic submissions.
• Experience with Veeva Vault RIM or similar regulatory systems preferred.

🎁 Benefits

• Culture grounded in scientific rigor and inclusive collaboration.
• Opportunity to shape regulatory strategy across development programs.
• Collaborative, cross-functional team environment.