CMC Regulatory Consultant

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.

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.