Regulatory Affairs Director

6 days ago


Rockville, Maryland, United States MaxCyte Inc Full time
Job Description

The Director, Regulatory Affairs will oversee the Regulatory function at MaxCyte, driving regulatory compliance and strategy to support business needs and safety, quality, and regulatory requirements. The role requires a deep understanding of global regulatory agencies, regulations, and standards.

Responsibilities
  • Regulatory Strategy and Compliance: Develop and implement regulatory strategies that ensure MaxCyte meets business needs and safety, quality, and regulatory requirements.
  • Master File Maintenance: Maintain and update existing Master Files in various countries to ensure compliance with global regulatory agencies.
  • Regulatory Process Development: Create and implement effective regulatory processes and procedures to deliver efficient and robust development plans.
  • Cross-Functional Collaboration: Partner closely with Legal, Quality, Manufacturing, Engineering, Business Development, Commercial, and other areas of the organization to ensure timely and strategic submissions.
  • Risk Management: Identify and diminish quality and regulatory risks in collaboration with colleagues and stakeholders.
Requirements
  • A BS/BA in science or engineering field with at least 8-10 years of leadership experience and at least 8 years of relevant regulatory experience within biologics drug development, ideally in cell and gene therapy.
  • Advanced degrees (MA/MS/Ph.D.) preferred.
  • Solid understanding of global regulatory and legal liability issues, including knowledge of FDA-regulated environments.
  • Hands-on experience in global DMF filings and compliance.
  • Strong verbal and written communications skills to convey complex regulatory requirements in a straightforward and practical manner.
Benefits
  • A comprehensive benefits package, including health, dental, vision, life, and disability insurance.
  • Generous time off.
Compensation

The estimated salary for this role is $210,000 - $229,000 per year, depending on experience, plus annual bonus and equity.



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