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Parexel · 2 days ago

Regulatory CMC Project Manager

United States

Full-time

Remote

Mid Level

3+ years exp

Parexel is committed to partnering with clients to bring innovative treatment options to patients. They are seeking a dedicated and detail-oriented Regulatory CMC Project Manager to play a pivotal role in their regulatory affairs department, focusing on project management and regulatory support.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

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

Qualification

Regulatory AffairsCMC ExperienceProject ManagementMicrosoft Office SuiteProject Management SoftwareOrganizational SkillsCommunication SkillsTime ManagementInterpersonal Skills

Required

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

Company

Parexel

Glassdoor3.9

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)