Regulatory Affairs Program Manager

Join to apply for the Regulatory Affairs Program Manager role at Bicara Therapeutics

Join to apply for the Regulatory Affairs Program Manager role at Bicara Therapeutics

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Bicara Therapeutics

Senior Manager, Talent Acquisition at Bicara Therapeutics

Position Overview:

Bicara Therapeutics is seeking a proactive and detail-oriented Regulatory Affairs Program Manager to contribute to the development of regulatory strategies and to coordinate regulatory activities across the product lifecycle. This individual will report to the Head of Regulatory Affairs, based in the US. The individual who fills this position will work closely with regulatory leadership, cross-functional teams and external partners to support product development activities.

Key Responsibilities:

• Help develop and implement regulatory strategies to support the advancement and approval of investigational products
• Perform regulatory landscape and regulatory precedent research to support regulatory scenario analyses and strategic plans
• Monitor and interpret changes in global regulatory requirements and guidelines, providing guidance to internal teams on their impact.
• Lead preparation, review, and submission of routine regulatory submissions.
• Support preparation and submission of complex regulatory submissions.
• Ensure compliance within U.S regulations (IND and NDA/BLA requirements),
• Collaborate with external partners, including contract research organizations (CROs), and regulatory consultants.
• Contribute to cross-functional program teams, ensuring alignment on goals and timelines.
• Assist with preparation for FDA meetings and interactions.
• Maintain organized and accurate regulatory documentation for audit readiness.
• Support lifecycle management strategies and post-marketing regulatory activities as needed.

Qualifications:

• Bachelor’s degree in life sciences or a related discipline required; advanced degree (PharmD) strongly preferred
• Minimum 2-4 years of experience in regulatory affairs within the biotech or pharmaceutical industry strongly preferred
• Oncology experience strongly preferred
• Ability to work independently and in a team environment
• Strong verbal and written communication skills
• Strong analytical thinking skills to assess regulatory research/guidance and support the development of regulatory strategy
• Detail-oriented, organized, and able to manage multiple or changing priorities in a fast-paced environment

Company Overview:

Bicara Therapeutics is a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors. Bicara’s lead program, ficerafusp alfa, is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-β). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-β signaling within the tumor microenvironment. Ficerafusp alfa is being developed in head and neck squamous cell carcinoma, where there remains a significant unmet need, as well as other solid tumor types. For more information, please visit or follow us on LinkedIn or X.

Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.

Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

Referrals increase your chances of interviewing at Bicara Therapeutics by 2x

Get notified about new Program Manager jobs in Boston, MA .

Boston, MA $80,000.00-$120,000.00 2 months ago

Program Manager - Product Commercialization

Boston, MA $84,000.00-$114,000.00 2 weeks ago

Cambridge, MA $138,600.00-$257,400.00 1 week ago

Senior Project Manager - Luxury Residential Construction

Somerville, MA $177,000.00-$266,000.00 1 day ago

Senior/Executive Director, Program Management (EU/US)

Cambridge, MA $261,000.00-$293,000.00 3 days ago

Project Manager, Programs and Facilities

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.