CMC Regulatory Consultant
Mexico, Remote Additional Locations: Buenos Aires, Argentina; Lima, Lima, Peru; Santiago, Region Metropolitana de Santiago, Chile 职位编号 R0000032353 类别 Consulting关于这个职位
Join our dynamic team at Parexel, where we are committed to excellence in regulatory affairs. We are seeking a highly skilled CMC Regulatory Project Manager (RPM CMC) to support our Regulatory CMC and Technical Development teams.
Location: Remote (Must be able to work East Coast- US hours regardless of physical location)
What you will be doing:
Submission Planning and Management:
- Prepare comprehensive table of contents for CMC/Module 3 submission deliverables.
- Establish start/end timelines and identify ownership for each deliverable.
- Track deliverables from initiation of authorship through approval.
- Ensure submissions are completed on time and meet high-quality standards.
Regulatory Planning:
- Develop and maintain a high-level global regulatory plan tracker under the direction of the Regulatory CMC Lead.
- Illustrate timing of key Regulatory CMC activities for the program.
Project Management:
- Serve as project manager for meetings, following standard best practices for meeting conduct.
- Manage meeting materials effectively.
Health Authority Engagement:
- Support the preparation of materials for health authority engagements.
Cross-functional Collaboration:
- Coordinate effectively with Regulatory CMC and Technical Development teams.
Qualifications:
- Bachelor's degree in a relevant scientific field; advanced degree preferred.
- 3+ years of experience in regulatory affairs in CMC.
- Strong project management activities skills and experience. (Managing and tracking deliverables)
- Excellent organizational and time management abilities.
- Proficient in Microsoft Office Suite.
- Strong English language communication and interpersonal skills.
- Ability to work in a fast-paced, deadline-driven environment.
Why Join Us? At Parexel, we value our employees and offer a collaborative and supportive work environment. We provide opportunities for professional growth and development, and we are dedicated to making a positive impact in the regulatory affairs industry.
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