Regulatory Affairs Lead

6 days ago

Rockville, Maryland, United States MaxCyte Inc Full time

MaxCyte Inc is a leading company in the field of biologics drug development, particularly in cell and gene therapy. We are currently seeking a highly skilled Regulatory Affairs Lead to join our team.

The salary range for this role is $210,000 - $229,000 per year, with opportunities for annual bonuses and equity participation. Our comprehensive benefits package includes health, dental, vision, life, and disability insurance, as well as generous time off.

About the Role:

The Director, Regulatory Affairs will be responsible for heading the Regulatory function at MaxCyte. This individual will develop and implement regulatory compliance and strategies that enable us to meet business needs, safety, quality, and regulatory requirements.

Key Responsibilities:

  • Research and Interpretation: The successful candidate will 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.
  • Master File Maintenance: They will maintain and update existing Master Files in various countries, ensuring timely and strategic submissions.
  • Regulatory Strategies: The Regulatory Affairs Lead will create and implement effective regulatory strategies to deliver an efficient and robust development plan.
  • Cross-Functional Collaboration: This individual will partner closely with Legal, Quality, Manufacturing, Engineering, Business Development, Commercial, and other areas of the organization to ensure timely and strategic submissions.
  • Risk Management: They will support projects and product teams to prioritize and identify issues that may increase regulatory risks and propose strategies to address such risks.
  • Process Development: The Regulatory Affairs Lead will develop regulatory processes and procedures and implement best practices.
  • Regulatory Agency Interactions: They will effectively plan, organize, and participate in meetings with regulatory agencies to ensure review and acceptance of master files and development plans.
  • Quality and Regulatory Risks: This individual will identify and diminish quality and regulatory risks in collaboration with other colleagues and stakeholders.
  • Consultant and Auditor Interface: The Regulatory Affairs Lead will interface with consultants, auditors, regulatory advisors, and other external experts.
  • Regulatory Impact Assessment: They will assess the impact of changing regulations on submission and product development strategies and update internal/external stakeholders in a timely manner.
  • Policies and Procedures: The successful candidate will comply with all applicable policies regarding health, safety, and the environment.

Requirements:

  • Education and Experience: A Bachelor's degree in a 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 is preferred.
  • Advanced Degrees: An advanced degree (MA/MS/Ph.D.) is preferred.
  • Regulatory Knowledge: The successful candidate will have a solid understanding of global regulatory and legal liability issues, demonstrated knowledge of regulatory standards and processes, predominantly in FDA-regulated environments.
  • Global DMF Filings: They will have hands-on experience in global DMF filings and compliance.
  • Problem-Solving: The Regulatory Affairs Lead will have a proven track record of success in problem-solving and developing risk-based solutions.
  • Communication Skills: Strong verbal and written communication skills are essential, with the ability to convey complex regulatory requirements in a straightforward and practical manner.
  • Business Acumen: The successful candidate will display good business acumen.
  • Cross-Functional Teams: Experience working on cross-functional teams to drive change and successful implementation is required.
  • Industry Trends: Understanding of relevant industry trends and regulatory developments and changes is necessary.
  • Relationship Building: The Regulatory Affairs Lead will build and cultivate strong relationships with internal and external stakeholders.

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