Regulatory Affairs Director

5 days ago

San Francisco, California, United States Stirling Q&R Full time
Job Overview

Stirling Q&R is seeking an accomplished and results-driven Senior Manager of Regulatory Affairs to lead the efforts in developing and executing regulatory strategies for our client's product portfolio.

Key Responsibilities:

  • Develop and execute global regulatory strategies for assigned products throughout their lifecycle.
  • Provide regulatory guidance to cross-functional teams on a wide range of issues.
  • Anticipate and resolve potential regulatory challenges consistent with business objectives.
  • Lead the preparation, review, and submission of high-quality regulatory documents, including INDs, NDAs, BLAs, and their international equivalents.
  • Respond to and manage health authority queries/information requests.
  • Guide interactions with regulatory agencies, including FDA and EMA.
  • Prepare for and participate in key regulatory meetings.
  • Establish and maintain positive relationships with regulatory authorities.
  • Mentor junior Regulatory Affairs professionals and emphasize continuous improvement and Regulatory excellence within the team.

Requirements:

  • Advanced degree in life sciences preferred (Ph.D., Pharm.D. or M.D.).
  • Minimum of 8-10 years pharmaceutical industry experience in Regulatory Affairs, with at least 3 years in a supervisory role.
  • Strong understanding of regulatory requirements of FDA, EMA, and ICH throughout the product development process.
  • Proven track record of successful submissions and approvals with excellent project management, communication, and leadership skills.

Benefits:

  • Competitive compensation package, including attractive base salary, annual bonus, comprehensive health and wellness benefits, 401(k) plan company match, generous paid time off, and holidays.
  • Professional development opportunities.

This is a great opportunity to make a real difference in the lives of patients while taking your career to the next level in a supportive and innovative environment.

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