Regulatory CMC Project Manager

Description

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

Qualifications

• 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.