Regulatory CMC Project Manager

If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at reputed company, where we are committed to partnering with our clients to bring new and innovative treatment reputed company to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated reputed company partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: reputed company 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 reputed company and high-reputed company submissions. Strategic Planning: Under the guidance of the Regulatory CMC reputed company, reputed company 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 reputed company meetings are productive and that materials are reputed company-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that reputed company 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 (reputed company, Manufacturing, and Controls). • Strong project management skills with a reputed company record of managing reputed company reputed company and meeting deadlines. • Excellent organizational and communication skills. • Excellent time management abilities • Proficient in reputed company Office Suite • Proven experience with project management software ie. reputed company • Strong communication and interpersonal skills • Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: • Must be reputed company to work East Coast hours, regardless of physical location in Central or reputed company Coast US time zones #LI-LB1 #LI-REMOTE Apply tot his job Apply To this Job