Rockefeller Philanthropy Advisors is hiring a Manager Regulatory CMC Strategy to play a key role shaping global regulatory Chemistry, Manufacturing, and Controls (CMC) strategies across the product lifecycle. You will prepare high-quality regulatory submissions, collaborate with cross-functional teams, and ensure regulatory compliance across multiple regions in a fast-paced, deadline-oriented setting.
What You'll Do
- Develop and execute regulatory CMC strategies aligned with global requirements for submissions, approvals, and lifecycle management.
- Lead resolution of complex issues, enabling informed decision-making in partnership with internal and external stakeholders.
- Collaborate with R&D, Quality, and Regulatory Affairs teams to align on submission content and timelines.
- Author and review regulatory CMC submissions including new registrations, variations, renewals, and responses to agency queries.
- Ensure accuracy and regulatory compliance of technical documentation and drive timely fulfillment of CMC-related commitments.
- Represent CMC on project teams, oversee project execution, and manage assigned regulatory portfolios with minimal supervision.
- Mentor junior team members and contribute to broader regulatory or organizational initiatives as needed.
What We're Looking For
- Bachelor’s degree in a scientific discipline
- At least 6 years of pharmaceutical industry experience
- Minimum of 2 years in CMC regulatory authoring
- Solid understanding of pharmaceutical development, manufacturing processes, and cGMP compliance
- Experience with lifecycle management, global regulatory submissions, and post-approval change management
- Strong verbal and written communication skills; comfortable interacting with diverse technical and regulatory audiences
- Proficiency in Microsoft Office and regulatory documentation systems (e.g., Documentum)
Nice to Have
- Advanced degree (MS, PhD, PharmD)
Technical Stack
- Microsoft Office
- Regulatory documentation systems (e.g., Documentum)
Team & Environment
You will collaborate with R&D, Quality, and Regulatory Affairs teams within a dynamic and collaborative environment.
Benefits & Compensation
- Competitive salary based on experience and qualifications
- Full remote flexibility, allowing you to work from anywhere
- Comprehensive healthcare coverage including medical, dental, and vision
- Paid time off and holidays
- Opportunities for continued professional development and mentorship
- Collaborative and inclusive work culture
Work Mode
This is a fully remote position open to candidates located anywhere.
Rockefeller Philanthropy Advisors is an equal opportunity employer.
