Senior Consultant - CMC Regulatory Affairs (M/F)

Joining Meent means?

Joining an expert engineering company in Life Science, created in 2023, which values the talent and energy of its employees to carry out innovative and ambitious projects.

At Meent Life Science, we build an adventure with our employees based on:

• Mutual aid and team spirit
• Benevolence and stability
• Fulfillment and professional progression

We believe that a fulfilled employee is a high-performing employee. That is why we offer a stimulating environment, training opportunities, and long-term support in your career.

The position:

• Define and lead the global Regulatory CMC strategy.
• Lead CMC activities related to MAA / NDA dossiers and supervise the preparation of Module 3.
• Guarantee the scientific, regulatory, and documentary consistency of submission dossiers.
• Prepare and support interactions with health authorities, notably EMA and FDA.
• Anticipate regulatory risks and propose appropriate mitigation strategies.
• Coordinate CMC, Regulatory Affairs, Quality, Production teams, and external partners.
• Lead responses to authority questions and ensure the follow-up of regulatory deliverables and deadlines.
• Ensure monitoring of ICH, EMA, FDA, and other international standards.

Profile sought:

• You have at least 10 years of experience in CMC Regulatory Affairs in the pharmaceutical industry.
• You have proven experience in leading Module 3 of MAA and/or NDA dossiers.
• You master the EMA, FDA, and ICH requirements applicable to CMC dossiers.
• Experience in international markets is highly appreciated.
• You have already defined and deployed Regulatory CMC strategies on an international scale.
• You are comfortable in matrix, international, and highly cross-functional environments.
• You are recognized for your leadership, analytical ability, rigor, and solution orientation.
• Fluent English is essential, both written and spoken.