CMC Regulatory Project Manager - Consultant, FSP (US or Canada)
United States of America, Remote Additional Locations Remote,North Carolina,United States of America Job ID R0000031392 Category Consulting Date Posted 02/20/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you!
Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department.
Key Responsibilities:
Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions.
Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements.
Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed.
Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards.
Health Authority Engagement: Support the preparation of materials for health authority engagements
Qualifications:
Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management).
3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls).
Strong project management skills with a track record of managing complex projects and meeting deadlines.
Excellent organizational and communication skills.
Excellent time management abilities
Proficient in Microsoft Office Suite
Strong communication and interpersonal skills
Ability to work collaboratively in a fast-paced, dynamic environment.
Additional Requirements:
Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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