Regulatory CMC Program Manager – Consulting
About The Position
The Regulatory CMC Project Manager is a client-facing consulting role responsible for providing project management support to Regulatory Chemistry, Manufacturing, and Controls (CMC) programs for pharmaceutical, biotechnology, and/or medical device clients across the product development lifecycle. This role partners with client teams to plan, structure, and drive execution of complex CMC and regulatory initiatives that support key development milestones, including INDs/CTAs, NDAs/BLAs, MAAs, supplements, variations, and approvals. Acting as both project leader and trusted advisor, the Regulatory CMC Project Manager ensures alignment between regulatory strategy, CMC development activities, and overall program objectives. The ideal candidate brings proven Regulatory CMC expertise, excellent client communication and facilitation skills, and the ability to manage multiple engagements in fast-paced, ambiguous environments.
Requirements
- Bachelor’s Degree (BS/BA) in life sciences, engineering, pharmacy, chemistry, or a related discipline
- 5+ years of project management experience supporting Regulatory Affairs and/or CMC activities
- Experience working in client-facing, consulting, or matrixed environments
- Strong understanding of drug development, manufacturing, and regulatory processes
- Ability to manage multiple concurrent projects
- Excellent written and verbal communication skills
- Comfort working with ambiguity and adapting to new client environments
- Proficiency with project management and collaboration tools such as MS Office, MS Project, Smartsheet, SharePoint, or similar platforms.
Nice To Haves
- Master’s Degree (MS), PharmD, or advanced degree in a scientific or regulatory discipline
- Life sciences consulting experience
- Experience supporting global regulatory submissions
- Familiarity with FDA, EMA, ICH, and global CMC regulatory expectations
- PMP or equivalent project management certification
- PMP preferred but not required.
Responsibilities
- Establish and lead cross-functional, high-performance program teams through effective planning and execution of projects
- Responsible for all project management activities including scoping, scheduling, budgeting, resourcing, and reporting as necessary to deliver program results in an efficient manner
- Drive development and execution of complex, integrated plans in alignment with strategic vision and operationalization
- A clear understanding of the critical path
- Balance and deliver on multiple assigned program/project objectives
- Demonstrate ability to recognize changing priority tasks
- Lead efficient, effective, and collaborative team meetings
- Drive team member ownership and engagement and production of key meeting outputs that drive meaningful action and decision
- Well-versed in risk management and able to develop and implement appropriate contingency and mitigation strategies
- Act as the single point of contact for project information
- Drive and maintain a collaborative and solution-focused communication style
- Skilled in analytics and data-driven decision-making and reporting
- Experience with a wide variety of project management methodologies
- Ability to match approach with people and project needs
- Focus on continual improvement and knowledge management
- Collaborating with PMO Leaders to evolve current state PM practices to best-in-class program management competencies across the company.
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What This Job Offers
Job Type
Part-time
Career Level
Mid Level
