Regulatory CMC Project Manager

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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

• Proven experience with project management software ie. Smartsheet

• 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 US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.