Executive Director, Regulatory Affairs

137358
  • Competitive
  • Austin, United States
  • Permanent

Meet is currently partnered with a cutting-edge biotech who are focused on developing therapies in Regenerative Medicine. My client is searching for an Executive Director/Vice President, Regulatory Affairs to lead their team!
 

Responsibilities:

  • Lead and manage the regulatory affairs team, providing strategic direction and guidance.
  • Develop and implement regulatory strategies for product development and approval in collaboration with cross-functional teams.
  • Interface with regulatory agencies to ensure clear and effective communication on regulatory submissions and approvals.
  • Collaborate with internal teams to prepare, review, and submit regulatory documents, including INDs, BLAs, and other submissions.

Qualifications:

  • Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
  • Therapeutic area background in regenerative medicine, stem cell therapy, gene therapy, etc.
  • Proven track record of successful interactions with regulatory agencies and obtaining regulatory approvals.
  • Experience in managing regulatory affairs teams and excellent communication skills.
Shannon Mattiolo Senior Recruiter

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