Regulatory Affairs Officer

Associate Director / Director, Regulatory Affairs

Role Overview :

Bicara Therapeutics is seeking an experienced and motivated Associate Director / Director of Regulatory Affairs to lead our regulatory strategy and execution in the EU. This individual will report to the US based Head of Regulatory Affairs and should have a proven track record in guiding regulatory processes for novel therapeutics. This individual will work closely with cross-functional teams and external partners to support the development and approval of our regulatory strategy abroad.

Responsibilities :

• Develop and execute regulatory strategies to support the advancement and approval of investigational products within the EU.
• Work closely with the Head of Regulatory Affairs to align strategies across different regions.
• Contribute to cross-functional program teams, providing strategic regulatory guidance throughout product development.
• Monitor current and emerging EU regulations, guidelines, and policies, advising the company on potential impacts.
• Anticipate regulatory risks and navigate evolving regulatory landscapes; proactively address potential challenges and opportunities.
• Lead the preparation, review, and submission of high-quality regulatory documents, including applications and amendments.
• Ensure compliance with applicable global regulations (EMA, ICH, etc.) and company policies.
• Collaborate with external partners, including contract research organizations (CROs), and regulatory consultants.
• Monitor and interpret evolving regulatory guidelines to keep Bicara at the forefront of compliance.
• 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 discipline (advanced degree preferred)
• 7-10 years of experience in regulatory affairs within the biotech or pharmaceutical industry
• Expertise in EU specific regulatory strategy required
• Oncology experience required
• Experience prepping a team for health authority meetings
• Proven track record of leading successful EU-based regulatory submissions
• Deep knowledge of global regulatory requirements, including FDA and EMA guidelines
• Strong leadership and project management skills; ability to influence cross-functional teams
• Exceptional communication and negotiation skills, including experience interacting with health authorities
• Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment

Company Overview :

Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to combine the precision of targeted therapy with the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1 / 1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at www.bicara.com.

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. We celebrate diversity and are committed to creating an inclusive environment for all employees.

To apply, please email your resume / CV to [emailprotected] . In the subject line include your name and the job title.

Seniority level

• Director

Employment type

• Full-time

Job function

• Science
• Biotechnology Research and Pharmaceutical Manufacturing