Bicara Therapeutics

Regulatory Regulatory Affairs Program Manager Boston, Massachusetts (Boston)

BOSTON, MAPosted 19 days ago

Job summary

  • Job post source

    This job is directly from Bicara Therapeutics

  • Job overview

    The Regulatory Affairs Program Manager at Bicara Therapeutics will lead regulatory strategy development and coordinate regulatory activities to support product lifecycle and approval processes.

  • Responsibilities and impact

    The role involves developing regulatory strategies, conducting regulatory research, monitoring global regulatory changes, preparing and submitting regulatory documents, ensuring compliance with US regulations, collaborating with external partners, supporting FDA interactions, and maintaining regulatory documentation.

  • Experience and skills

    Candidates should have a bachelor's degree in life sciences or related field, with an advanced degree preferred, 2-4 years of regulatory affairs experience in biotech or pharma, preferably in oncology, strong communication and analytical skills, and ability to manage multiple priorities.

  • Work environment and culture

    Bicara Therapeutics values diversity and inclusion, fostering a culture where all voices are heard and encourages applicants from all backgrounds.

  • Company information

    Bicara Therapeutics is a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, with a lead program targeting EGFR and TGF-beta pathways in cancer treatment.

  • Job location and travel

    The position is based in Boston, Massachusetts, reporting to the Head of Regulatory Affairs in the US.

  • Unique job features

    The role offers involvement in innovative bifunctional antibody therapies targeting solid tumors, with opportunities to impact regulatory strategy in a clinical-stage biotech environment.

Company overview

Bicara Therapeutics is a biotechnology company focused on developing innovative cancer therapies. They specialize in creating bifunctional antibodies that target both the immune system and the tumor microenvironment to enhance anti-tumor activity. The company generates revenue through partnerships, licensing agreements, and the development of proprietary therapies. Founded in 2019, Bicara has rapidly advanced its pipeline, leveraging cutting-edge science and strategic collaborations to address unmet medical needs in oncology.

How to land this job

  • Tailor your resume to emphasize your experience in regulatory affairs within biotech or pharmaceutical industries, especially highlighting any oncology-related work, as Bicara Therapeutics values this expertise.

  • Showcase your skills in developing and implementing regulatory strategies, managing IND and NDA/BLA submissions, and collaborating with cross-functional teams and external partners like CROs.

  • Apply through multiple platforms including Bicara Therapeutics' official careers page, LinkedIn, and other biotech job boards to maximize your application visibility.

  • Connect with current Regulatory Affairs team members or leadership at Bicara Therapeutics on LinkedIn; use ice breakers such as mentioning the company's innovative bifunctional therapies or asking about their approach to regulatory challenges in oncology.

  • Optimize your resume for ATS by incorporating keywords from the job description like 'regulatory strategy,' 'IND/NDA/BLA submissions,' 'oncology,' 'cross-functional collaboration,' and 'FDA interactions' to ensure it passes initial screenings.

  • Consider using Jennie Johnson's Power Apply feature to automate tailored resume customization, identify multiple application channels, and find relevant LinkedIn contacts, allowing you to focus more on preparing for interviews and networking.

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