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Regulatory CMC Project Manager

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Parexel

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Location:
United States

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

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.

Job Responsibility:

  • 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

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
  • Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones
What we offer:
  • Flexibility of working remotely
  • Part of a supportive and dynamic team
  • Supportive and inclusive environment
  • Opportunities for career growth
  • Flexible work arrangements
  • Diverse and global client exposure
  • Learn from experts

Additional Information:

Job Posted:
January 09, 2026

Work Type:
Remote work
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