Regulatory Affairs Director

2 weeks ago


Rockville, Maryland, United States MaxCyte Inc Full time
Job Title: Director, Regulatory Affairs

MaxCyte Inc is seeking a highly experienced Director, Regulatory Affairs to lead the Regulatory function and develop strategies that enable the company to meet business needs, safety, quality, and regulatory requirements.

Key Responsibilities:
  • Develop and implement regulatory compliance and strategies to ensure governmental approvals are obtained.
  • Research and interpret regulations, guidance's, and precedents to support interdepartmental project teams in developing strategies, policies, and procedures that ensure regulatory compliance with global regulatory agencies.
  • Maintain and update existing Master Files in various countries.
  • Create and implement effective regulatory strategies to deliver an efficient and robust development plan.
  • Partner closely with Legal, Quality, Manufacturing, Engineering, Business Development, Commercial, and other areas of the organization to ensure timely and strategic submissions.
  • Support projects and product teams to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
  • Develop regulatory processes and procedures and implement best practices.
  • Effectively plan, organize, and participate in meetings with regulatory agencies.
  • Lead and or participate in communications and meetings with various global Regulatory Authorities to ensure the review and acceptance of master file and development plans, the timely resolution of issues, and the approval of client marketing applications.
  • Identify and diminish quality and regulatory risks in collaboration with other colleagues and stakeholders.
  • Interface with consultants, auditors, regulatory advisors.
  • Assess impact of changing regulations on submission and product development strategies and updates internal/external stakeholders in a timely manner.
Requirements:
  • 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. Experience in life sciences tools and enabling technologies preferred.
  • Advanced degrees (MA/MS/Ph.D.) preferred.
  • Solid understanding of global regulatory and legal liability issues. Demonstrated knowledge of regulatory standards and processes, predominantly in FDA-regulated environments.
  • Hands-on experience in global DMF filings and compliance.
  • Proven track record of success in problem solving and developing risk-based solutions.
  • Strong verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.
  • Displays good business acumen.
  • Proven track record of success in problem solving and developing risk-based solutions.
  • Experience working on cross-functional teams to driving change and successful implementation.
  • Understands relevant industry trends and regulatory developments and changes.
  • Strong written and oral communication skills.
  • Builds and cultivates strong relationships.

MaxCyte Inc offers a competitive compensation package, including a yearly salary of $00,000.



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