Manager Regulatory CMC f/m

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

Résumé du poste

A leading company in the pharmaceutical industry is seeking an expert in Global Regulatory Chemistry Manufacturing and Control (CMC) to lead strategy development and management of regulatory documentation. The ideal candidate will possess substantial experience in global regulatory affairs, with a strong emphasis on compliance and successful submission strategies. This high-impact role requires strategic thinking, exceptional organizational skills, and the ability to navigate complex regulatory environments.

Qualifications

• Minimum 5 years pharmaceutical industry experience, with at least 2 years in Global regulatory affairs (CMC).
• Proven ability to develop and prepare successful regulatory strategies.
• Excellent written and spoken English; knowledge of French and German is a plus.

Responsabilités

• Develop and manage Global Regulatory CMC strategy for projects.
• Oversee regulatory CMC activities ensuring compliance and timely delivery.
• Provide expertise to stakeholders regarding country-specific requirements.

Connaissances

Regulatory CMC strategy development

Documentation management

Manufacturing process development

Pharmaceutical legislation knowledge

Communication skills

Organizational skills

Formation

Degree in Life Science or related discipline (MSc/PhD preferred)

Description du poste

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.

The role requires international travels for business meetings, visit of manufacturing sites for key stakeholder interactions and technical meetings.

Please write and send a CV and cover letter in English.

Who you are:

• 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.