Director of Regulatory Affairs

Direct message the job poster from Meet Life Sciences

A well-established life sciences consultancy is seeking an experienced Director of Regulatory Affairs to provide strategic and operational leadership across regulatory and clinical research activities. This role partners closely with executive leadership and plays a key role in guiding regulatory strategy, ensuring compliance, and supporting business growth across a diverse portfolio of pharmaceutical, biologic, and device programs.

This position offers the opportunity to lead high-impact initiatives, mentor teams, and act as a trusted advisor to both internal stakeholders and external clients in a fully remote, East Coast–based role.

• Lead and oversee all Regulatory Affairs activities, with responsibility for regulatory strategy, submissions, and compliance across U.S. and international programs.
• Plan, manage, and deliver multiple regulatory and clinical research–related projects in alignment with organizational and client objectives.
• Oversee the development, review, and implementation of SOPs and work processes in collaboration with Quality Assurance.
• Manage, coach, and develop Regulatory Affairs and Clinical Research staff, including staffing, training, and performance management.
• Serve as a senior liaison to executive leadership, internal teams, and clients; represent the organization in client interactions as delegated by the President & CEO.
• Support business development efforts by providing regulatory expertise during proposals, client discussions, and strategic planning.
• Contribute to departmental planning, prioritization, and resource allocation to ensure timely and high-quality delivery.
• Participate as a member of the management team, with responsibility for budgeting and financial oversight for Regulatory Affairs.
• Make supervisory and strategic decisions to ensure regulatory excellence and continuous improvement.

• Demonstrated leadership experience in Regulatory Affairs within the pharmaceutical, biologics, and/or medical device sectors.
• In-depth knowledge of U.S. and international regulatory frameworks and submission pathways.
• Strong communication, organizational, and stakeholder management skills, with the ability to influence at senior levels.
• Recognized expertise in a scientific or technical discipline, with evidence of external credibility through publications, presentations, or professional involvement.
• Proven ability to lead, mentor, and develop high-performing teams.
• Experience implementing efficient systems, tools, and processes to support regulatory operations.
• A track record of managing multiple projects, setting priorities, and driving change in complex environments.

• PhD, MD, MS/MA, or equivalent experience in a scientific or health-related field, with relevant coursework in management and preclinical or clinical research,
  or
• 7+ years of experience in research and development, including direct project leadership, personnel planning, and budget management.

Director

Full-time

Other

Pharmaceutical Manufacturing and Biotechnology Research