Director, Regulatory Affairs CMC US
About The Position
The Director, Regulatory Affairs CMC provides strategic CMC regulatory leadership across complex client programs, supporting development, submissions, and lifecycle activities. The role leads major client projects and serves as a senior client-facing advisor, ensuring delivery against timelines, quality, and financial objectives. It drives regulatory strategy, health authority interactions, and scientific advice activities using extensive CMC expertise. The Director supports business growth through proposal development, bid defenses, client relationship management, and identification of new opportunities. The role also contributes to Practice Area operational excellence through mentoring, coaching, and team member development. It provides leadership and resource oversight for the US CMC team, including staffing, capability development, and delivery support across projects, and supports operational performance through recruitment, coaching, utilization management, and collaboration with Practice Area leadership.
Requirements
- Bachelor's degree in business administration, healthcare management, or a related field, or equivalent experience.
- 10+ years of experience in scientific consulting, healthcare, life sciences, or a related field.
- 5+ years of experience in a management capacity.
Nice To Haves
- Master's degree in business administration, healthcare management, or a related field, or equivalent experience.
- Certification in clinical research or regulatory affairs.
- Certification in health economics, outcomes research, or real-world evidence methodologies.
Responsibilities
- Provide strategic CMC regulatory leadership across complex client programs, supporting development, submissions, and lifecycle activities.
- Lead major client projects and act as a senior client-facing advisor, ensuring delivery against timelines, quality, and financial objectives.
- Drive regulatory strategy, health authority interactions, and scientific advice activities using CMC expertise.
- Support business growth through proposal development, bid defenses, client relationship management, and identification of new opportunities.
- Contribute to Practice Area operational excellence through mentoring, coaching, and development of team members.
- Provide leadership and resource oversight for the US CMC team, ensuring appropriate staffing, capability development, and delivery support across projects.
- Support business growth and operational performance through recruitment, coaching, utilization management, and collaboration with Practice Area leadership.
Benefits
- Medical, dental, and vision care.
- Backup dependent care may be available.
- Adoption assistance.
- Infertility coverage.
- Family building support.
- Behavioral health solutions.
- Paid parental leave.
- Paid caregiver leave.
- Training programs and professional development resources.
- Mentorship programs.
- Employee resource groups.
- Volunteer activities.
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What This Job Offers
Job Type
Full-time
Career Level
Director
