Sr Manager, Regulatory Affairs CMC

Role Summary

The CMC Regulatory Affairs Project Manager is responsible for supporting the planning, coordination, and execution of CMC regulatory activities across global clinical and commercial programs. This role partners closely with Regulatory Affairs, Technical Development, Quality, and cross-functional CMC teams to support timely, compliant, and well-organized submissions to global health authorities.

Responsibilities

• Coordinate and track timely regulatory assessments of CMC change controls to support global filing impacts for the development of CMC filing strategies and timelines
• Support and track CMC regulatory project activities, including global quality dossier preparation, global dossier lifecycle submissions, approval, and Health Authority communications/interactions.
• Manage CMC RA product team meetings (i.e., meeting agendas, meeting materials, document meeting minutes, discussion outcomes and follow-up on action items). Compile and monitor product portfolio including scope, priorities, milestones and emerging regulatory risks to product variants
• Maintain and track global CMC regulatory filing plans, project timelines, and metrics that support visibility, alignment, and execution across product variants.
• Coordinate CMC RA product team and technical content author activities to ensure high-quality submission content through stakeholder engagement, clear communication, and timely resolution of issues.
• Track and organize CMC filing related documentation (e.g., data availability timelines, validation data, specifications, analytical methods, stability data, Module 3 content).
• Support regulatory strategy development by identifying and tracking regulatory fileability risks.
• Lead meeting logistics and documentation, including agendas, minutes, and action item tracking, and follow-up.
• Serve as a liaison with PDM product and portfolio Project Managers for CMC RA topics, including timelines and project milestones for preparation of global regulatory submissions, Health Authority briefing packages, responses, and meeting materials.
• Contribute to process improvements, best-practice development, and regulatory CMC initiatives.

Qualifications

• Required: Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or related discipline.
• Required: Min. 4–6+ years of relevant experience in pharmaceutical project, CMC development, CMC Regulatory Affairs.
• Preferred: Strong project management skills with a track record of managing complex projects and meeting challenging deadlines. Prior experience in regulatory and CMC project management preferred.
• Preferred: Excellent organizational, time management and problem-solving skills.
• Preferred: Excellent communication, and interpersonal skills.
• Preferred: High attention to detail and strong ability to think critically.
• Preferred: Proven experience with project management tools (i.e., Microsoft Office Suite, Smartsheet, Visio, Thinkcell, Microsoft Project).
• Preferred: Ability to work collaboratively in a fast-paced, dynamic environment.

Skills

• Project management capability with a track record of delivering complex regulatory projects on time.
• Strong organizational, time management, and problem-solving abilities.
• Excellent written and verbal communication and interpersonal skills.
• High attention to detail and critical thinking.
• Proficiency with project management tools (e.g., Microsoft Office Suite, Smartsheet, Visio, Thinkcell, Microsoft Project).
• Ability to collaborate effectively in a fast-paced, dynamic environment.