Manager Regulatory CMC

Merck; Lyon; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading pharmaceutical company is seeking an individual contributor to develop and execute the Global Regulatory CMC strategy for Life Cycle Management programs. The ideal candidate will possess a strong background in regulatory affairs with at least five years' experience in the pharmaceutical industry, particularly focused on Chemistry Manufacturing and Control. This high-impact role involves overseeing various projects and ensuring compliance with country-specific regulations, while also authoring necessary documentation. Excellent communication skills in English and knowledge of other languages are essential for success in this dynamic environment.

Qualifications

• Minimum of 5 years of pharmaceutical industry experience, with at least 2 years in global regulatory affairs.
• Strong ability to develop successful regulatory CMC strategies.
• Extensive experience in international submissions and large variations.

Responsabilités

• Develop and manage Global Regulatory CMC strategy for assigned projects/products.
• Oversee regulatory CMC activities for timely delivery and quality compliance.
• Provide regulatory CMC expertise to key stakeholders.

Connaissances

Regulatory CMC strategy

Documentation preparation

Communication skills in English

Knowledge of pharmaceutical legislation

Organizational skills

Formation

Degree in Life Science or related discipline

PhD in a scientific discipline

Description du poste

Cadre

Your role

• As an individual contributor in our organization, your role is crucial for developing and executing the Global Regulatory Chemistry Manufacturing and Control (CMC) strategy for Life Cycle Management programs. The ideal candidate will have a strong background in regulatory affairs, particularly in CMC, and should demonstrate excellence in designing CMC regulatory strategy and dossier strategy for various projects and products.
• Your role involves developing and managing the Global Regulatory CMC strategy for assigned projects / products across various regions. Responsibilities include overseeing regulatory CMC activities to ensure timely delivery and quality compliance, as well as authoring and maintaining the CMC Dossier Strategy Document and related registration dossier (NDA / MAA, variations, etc.). The role will provide regulatory CMC expertise to key stakeholders, ensuring adherence to country-specific requirements and evaluating Change Control proposals.
• Given the significant business impact and dynamic life-cycle management environment, your role is high-demand, and fast-paced. It involves managing critical business topics, necessitating resilience and learning agility.

Profile

• You have a Degree in a Life Science or related discipline (e.g., MSc or equivalent degree; PhD in a scientific discipline is preferred), a minimum of 5 years of pharmaceutical industry experience, with at least 2 years of experience in Global regulatory affairs (GRA) related to Chemistry Manufacturing and Control (CMC).
• You possess a strong ability to develop and prepare successful regulatory CMC strategies and dossiers.
• You have extensive experience in the preparation and management of regulatory CMC documentation, including full international submissions and large variations.
• You hold practical experience in manufacturing process development, transfers, validation, or analytical development and control strategies.
• You have in-depth knowledge of global pharmaceutical legislation and regulatory affairs.
• Your excellent written and spoken communication skills in English are complemented by knowledge of other European languages, such as French and German.
• You are strategic in your thinking, detail-oriented, and possess excellent organizational and planning skills.