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Director Regulatory Strategy

4 months ago

Cambridge, United States Meet Full time

Join this company in a pivotal role where your expertise will advance our mission of utilizing innovative science to develop impactful cancer treatments. This position offers the chance to influence and drive regulatory strategies that align with our cutting-edge oncology assets, fostering collaboration with the FDA to expedite the development and approval of new therapies.

Key Responsibilities:

  • Regulatory Strategy Development: Formulate and implement US regulatory strategies for assigned projects, ensuring alignment with overall development plans. Prepare for and strategize FDA meetings.
  • FDA Liaison: Serve as the primary point of contact with the FDA. Lead negotiations, organize meetings and teleconferences, and maintain effective communication channels.
  • Submission Management: Oversee and prepare FDA submissions, including briefing documents, breakthrough therapy designation requests, and orphan drug applications.
  • Global Project Collaboration: Participate in global project team meetings for both development and marketed products, providing regulatory guidance and managing daily regulatory activities. Collaborate across all disciplines within the organization to gather necessary information for regulatory filings.
  • Regulatory Representation: Potentially serve as the sole regulatory representative on study teams, offering expert guidance.
  • Guideline Review and Interpretation: Stay informed of and interpret relevant regulatory guidelines to ensure compliance and strategic alignment.
  • Continuous Learning: Keep abreast of regulatory updates by attending relevant meetings, seminars, and conferences, and by engaging with scientific literature and other resources.

Qualifications:

  • Education:
  • Bachelor's Degree (required)
  • Advanced degree (e.g., Master's, PharmD, Ph.D., MD, JD) (preferred)
  • Experience:
  • 10+ years in the pharmaceutical industry
  • 8+ years in regulatory affairs
  • Proven experience in providing strategic regulatory input throughout the drug development process, with comprehensive knowledge of IND and NDA/BLA processes.
  • Familiarity with US pharmaceutical regulations and global regulations (such as ICH) is highly desirable. Experience with (s)NDA/BLA filings to the FDA is a plus.

Competencies:

  • Communication: Excellent oral and written communication skills, strong interpersonal skills, and the ability to thrive in a team environment.
  • Stress Management: Ability to perform effectively in high-pressure, deadline-driven situations.
  • Motivation and Multi-tasking: Energetic, self-motivated, and adept at handling multiple tasks simultaneously.
  • Organizational Skills: Proactive, disciplined, and detail-oriented, with a keen eye for detail.
  • Analytical Thinking: Ability to think logically and objectively, identifying significant problems and opportunities.

Travel:

  • Ability to travel up to 30% for this in-house position, which may include occasional global travel.