Associate Director/Director - Regulatory Affairs - Tbwa Chiat/Day : Job Details

Associate Director/Director - Regulatory Affairs

Tbwa Chiat/Day

Job Location : all cities,MA, USA

Posted on : 2025-01-18T09:24:03Z

Job Description :
Associate Director/Director - Regulatory Affairs

Role:

Be Biopharma is looking to hire highly motivated, experienced, and innovative thinkers to join our growing team of passionate researchers to leverage B cells as a novel class of cellular medicine. This is an exciting opportunity to be part of a foundational team and help build Be Bio!

This highly dynamic team is seeking an entrepreneurial and strategic (Associate) Director, Regulatory Affairs to play a key role on our cross-functional R&D team. In this role, you will have the opportunity to lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. The individual in this position will have the unique opportunity to shape the Regulatory function of a rapid-growth biotech startup.

Responsibilities:

  • Lead and contribute to regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure global regulatory requirements and strategy are understood by project teams.
  • Play a hands-on role in planning, preparing, and coordinating regulatory documents for submission to global health authorities in support of regulatory filings, such as INDs, BLAs, MAAs, CTAs/IMPDs, amendments, annual updates, briefing documents, and responses to Agency queries.
  • Close collaboration with internal and external cross-functional team members to ensure achievement of submissions and timely approvals of applications.
  • Lead interactions with FDA and other Health Authorities.
  • Communicate project updates and risks to senior management and stakeholders across the organization. Track regulatory commitments, deliverables, and overall project timelines.
  • Maintain up-to-date knowledge and understanding of global regulatory requirements.
  • Initiate and contribute to the development of policies and procedures in alignment with GxPs, global regulatory requirements and guidance, and corporate objectives.

Experience, Education, Specialized Knowledge, and Skills:

  • 7-9 years of biopharmaceutical experience, which includes at least 5-6 years of direct experience in Regulatory Affairs.
  • Advanced degree (Master's or PhD) in a relevant scientific discipline is preferred.
  • Experience in cell and gene therapy or biologics drug development, orphan/rare disease product development.
  • Experience in developing and implementing regulatory strategies in a global environment.
  • Comprehensive understanding of applicable global regulations, guidance, and practices.
  • Demonstrated hands-on experience in the preparation and submission of global regulatory documents including clinical trial applications and maintenance (IND/CTA), NDA/BLA/MAA, briefing documents, and agency queries.
  • Prior experience leading interactions with FDA and other global regulatory authorities.
  • Strong verbal and written communication skills; ability to clearly articulate regulatory viewpoints to diverse internal and external audiences including executive leadership.

About Be Biopharma

Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BCM) to dramatically improve patients' lives who are living with cancer, rare diseases, and other serious conditions. Our team of purpose-driven scientists, technologists, manufacturing experts, and business builders collaborate to create a bold new class of cell therapies.

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