Regulatory Affairs Director: Strategic Leadership and Compliance Expert

5 hours ago


Massachusetts, United States Fairway Consulting Group Full time

Our client, a clinical stage biopharmaceutical company, is seeking a highly experienced Director of Regulatory Affairs to lead their global regulatory strategy and execution.

This senior role requires a comprehensive understanding of the drug development process, global regulations, and guidelines. The ideal candidate will have a proven track record of interacting with regulatory bodies and ensuring compliance with FDA, ICH, EMA, and industry standards.

The Director of Regulatory Affairs will be responsible for:

  • SUPPORTING GLOBAL REGULATORY STRATEGY AND EXECUTION ON DEVELOPMENT PROGRAMS
  • PROVIDING STRATEGIC REGULATORY LEADERSHIP AND GUIDANCE TO PROJECT TEAMS
  • COLLABORATING WITH VARIOUS DEPARTMENTS TO ENSURE ALIGNMENT WITH REGULATORY REQUIREMENTS THROUGHOUT THE PRODUCT LIFECYCLE

The successful candidate will possess significant regulatory affairs experience, preferably with experience taking a program through key development milestones with global regulatory bodies. A comprehensive knowledge of rare disease, neuromuscular, or neurodegenerative therapies is strongly preferred.

We estimate the salary for this position to be around $160,000 - $200,000 per year, based on industry standards and location.

Fairway Consulting Group is a leading executive search firm in the healthcare and life sciences sector, included in Hunt Scanlon's list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.



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