Parexel

Compensation

Full Description

Job Description: • Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. • Develop and maintain a high-level global regulatory plan tracker. • Serve as the project manager for meetings, ensuring productivity and effective materials management. • Assist in 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. Benefits: • N/A