CMC Regulatory Affairs Project Manager

Perrigo; Châtillon; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

A global company is seeking a CMC Regulatory Affairs Project Manager to lead complex CMC projects in healthcare. The role requires strong project management skills and a scientific background, emphasizing communication and regulatory expertise. The position offers career development in a hybrid working environment with competitive compensation.

Prestations

Competitive compensation

Career development opportunities

Hybrid working model (2 days remote)

Qualifications

• Minimum 7 years in CMC Regulatory Affairs or R&D.
• Self-motivated with excellent communication skills.
• Fluency in English, French desirable.

Responsabilités

• Lead CMC Regulatory Projects and update stakeholders.
• Develop regulatory strategies for new MAAs and lifecycle activities.
• Manage technical/quality sections of CMC dossiers.

Connaissances

Communication

Project Management

Risk Management

Formation

University Degree in scientific field

Description du poste

Within our global and international Scientific Affairs team, we're looking for a CMC Regulatory Affairs Project Manager to join our office in London (UK).

As a CMC Regulatory Affairs Project Manager, you will lead complex CMC projects across our healthcare portfolio, including territory extensions, new registrations, and new formulations. You will develop CMC strategies, execute site transfer and CMC projects, and contribute to functional change initiatives to improve team performance.

Scope of the Role

You will:

• Lead CMC Regulatory Projects, report progress, and update stakeholders.
• Develop regulatory strategies for new MAAs, product development, and lifecycle activities.
• Perform due diligence on product dossiers, identifying risks and opportunities.
• Support technical teams with scientific expertise for development and validation plans.
• Review technical documentation during site transfer projects and support Change Controls with RA assessments.
• Manage and write technical/quality sections of CMC dossiers, including complex variations.
• Ensure supply continuity, timely product submissions, and resolve regulatory issues with authorities.
• Provide support for MDR-related changes and emerging ingredient issues in compliance with guidance.
• Participate in quality management, including change requests and product reviews.
• Develop and maintain internal procedures, ensuring regulatory data integrity and compliance with legislation.

Experience Required

• University Degree or equivalent in a scientific field, with at least 7 years of relevant experience, preferably in CMC Regulatory Affairs or R&D.
• Experience with specific product types, healthcare products, and CMC lifecycle management.
• Knowledge of CMC dossiers (3.2.P and 3.2.S) and experience with Nitrosamines projects is a plus.
• Self-motivated, flexible, with excellent communication skills and ability to manage multiple projects.
• Fluency in English is mandatory; French is desirable.

Benefits

We offer competitive compensation, benefits supporting you and your family, and career development opportunities. Our hybrid working model allows two days remote work per week. We are proud to be listed in Forbes' "America's Best Employers by State 2024".

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