This position ensures for the HQ all regulatory and monitoring activities of the CMC part (module 3) on a drug portfolio, according to the group strategy and in accordance with the state of the art, the guidelines, and regulations in force. It supports the worldwide objectives of the HQ.

You will join a team of experts working in highly complex projects.

Position Duties & Responsibilities :

Under the responsibility of the Technical and Regulatory Service Manager, you will work with different departments in Headquarters and our affiliates, in direct connection with our manufacturing plant and our sub-contractors.

With a strong collaboration with the Registrations department, you will :

• Define strategies for drafting CMC / module 3 documents for new Marketing Authorisation Application (MAA), for variations and renewals files, worldwide.
• Prepare, draft and update module 3 of Marketing Authorisation dossiers and answer CMC questions from the competent Health Authorities.
• Interact with the Contract Manufacturing Organizations (CMOs) in charge of the manufacturing activities of the drug substances and drug products, including for the activities of process development, for development of analytical methods, etc.
• Assess the compliance of CMC dossiers by carrying out gap analyses of the documentation in accordance to the group Product Compliance Program and plan associated regulatory strategies to address any identified gaps.
• Contribute to the development/review of internal standard procedures related to CMC activities.
• Provide scientific and technical monitoring of projects.

You will also participate in quality activities (change controls, deviations, audits, CAPA).

EDUCATION & EXPERIENCE REQUIREMENTS :

Pharmacist Doctor, Master in Science or Engineering.

Minimum 5 years relevant / CMC experience is required.

Knowledge and understanding of the CMC and regulatory environment is required.

CMC Experience with biological products would be a plus.

FUNCTIONAL AND TECHNICAL COMPETENCIES :

• Rigor, critical thinking, and strong analytical and problem-solving skills.
• You can work in project mode; you have a sense of teamwork and ability to act as liaison with other departments where necessary.
• Excellent organizational and planning skills.
• Strong verbal and written communication skills in English; working in an international environment;
• Excellent interpersonal skills; relationship building skills.