Regulatory CMC Project Manager
Parexel
full-time
Posted on:
Location Type: Remote
Location: United States
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About the role
- Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables.
- Develop and maintain a high-level global regulatory plan tracker.
- Serve as the project manager for meetings, ensuring productivity and effective materials management.
- Assist in the preparation of materials for health authority engagements.
Requirements
- 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.
Benefits
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Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory affairsCMCproject managementmaterials preparationglobal regulatory plan tracking
Soft skills
organizational skillscommunication skillstime managementinterpersonal skillscollaborative skills
Certifications
Bachelor's degreeRegulatory Affairs certification