Regulatory Affairs Director

1 week ago


Rockville, Maryland, United States MaxCyte Inc Full time

MaxCyte Inc is a leading company in the field of cell and gene therapy. We are seeking an experienced Regulatory Affairs Director to head our Regulatory function.

The ideal candidate will have at least 8-10 years of leadership experience and 8 years of relevant regulatory experience within biologics drug development, preferably in cell and gene therapy.

Key Responsibilities:

  • Maintain current regulatory filings and interpret regulations to support interdepartmental project teams
  • Update existing Master Files in various countries and create effective regulatory strategies
  • Partner with cross-functional teams to ensure timely and strategic submissions
  • Support projects and product teams to identify and address regulatory risks
  • Develop and implement regulatory processes and procedures
  • Interface with consultants, auditors, and regulatory advisors

Requirements:

  • BS/BA in science or engineering field; advanced degrees preferred
  • Solid understanding of global regulatory and legal liability issues
  • Hands-on experience in global DMF filings and compliance
  • Strong verbal and written communications skills
  • Proven track record of success in problem solving and developing risk-based solutions
  • Experience working on cross-functional teams

The estimated salary for this role is $220,000 per year, based on industry standards and market trends.

MaxCyte offers a comprehensive benefits package, including health, dental, vision, life, and disability insurance, as well as generous time off.



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