CMC Regulatory Consultant
Mexico, Remote Additional Locations Buenos Aires,Argentina;Lima,Peru;Santiago,Chile Job ID R0000032353 Category Consulting Date Posted 03/24/2025Overview
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
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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