Job Description

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.

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

• Bachelors 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. Bicaras 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-). 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- 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.

Equal Opportunity

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.

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