Position Summary:
Bicara Therapeutics is seeking a Regulatory Affairs Program Manager to support regulatory strategy development and manage regulatory activities across the product lifecycle. Reporting to the Head of Regulatory Affairs, this role will work closely with internal teams and external partners to support product advancement and ensure compliance with global regulatory requirements.
Key Responsibilities:
- Support the development and implementation of regulatory strategies
- Conduct regulatory precedent research and monitor global regulatory changes
- Prepare and manage regulatory submissions (routine and complex)
- Ensure compliance with U.S. regulations (IND, NDA/BLA)
- Collaborate with CROs and regulatory consultants
- Support FDA meeting preparation and cross-functional program coordination
- Maintain accurate regulatory documentation and assist with lifecycle management
Qualifications:
- Bachelor’s degree in life sciences required; PharmD or advanced degree preferred
- 2–4 years of regulatory affairs experience in biotech/pharma (oncology preferred)
- Strong analytical, organizational, and communication skills
- Able to manage shifting priorities in a fast-paced environment
- Hybrid role based in Boston, MA
Job sourced from Bicara Therapeutics.