Regulatory Affairs Director

3 weeks ago

Rockville, Maryland, United States MaxCyte Inc Full time

The Director, Regulatory Affairs will lead the Regulatory function at MaxCyte. The successful candidate will develop and implement regulatory compliance and strategies that enable MaxCyte to meet business needs, as well as safety, quality, and regulatory requirements.

Key Responsibilities:

  • Interpret and implement regulatory requirements and regulations to maintain current regulatory filings, ensuring compliance with global regulatory agencies.
  • Develop and maintain existing Master Files in various countries, guaranteeing regulatory compliance.
  • Implement effective regulatory strategies to deliver efficient and robust development plans.
  • Collaborate with cross-functional teams, including Legal, Quality, Manufacturing, Engineering, Business Development, and Commercial, to ensure timely and strategic submissions.
  • Support projects and product teams in prioritizing and identifying regulatory risks and proposing strategies to address such risks.
  • Develop and implement regulatory processes and procedures, ensuring best practices.
  • Plan and participate in meetings with regulatory agencies, ensuring the review and acceptance of master files and development plans.
  • Lead communications and meetings with global Regulatory Authorities to ensure regulatory compliance.
  • Identify and mitigate quality and regulatory risks in collaboration with colleagues and stakeholders.

Requirements:

  • BS/BA in a science or engineering field, with at least 8-10 years of leadership experience and 8 years of relevant regulatory experience in biologics drug development, ideally in cell and gene therapy.
  • Advanced degrees (MA/MS/Ph.D.) preferred.
  • Strong understanding of global regulatory and legal liability issues, with knowledge of regulatory standards and processes in FDA-regulated environments.
  • Experience in global DMF filings and compliance.
  • Proven track record of success in problem-solving and developing risk-based solutions.
  • Excellent verbal and written communication skills, with the ability to convey complex regulatory requirements in a clear and practical manner.
  • Strong business acumen and ability to build and cultivate relationships.

This role offers a competitive compensation package, including a base salary range of $210,000 - $229,000, annual bonus, and equity, as well as a comprehensive benefits package.

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