CMC Regulatory Consultant H/F

The Regulatory CMC Department of our client is looking for a CMC Regulatory Consultant.

Mission: 

1. Regulatory CMC documentation 

• Coordinate/contribute to the life cycle management of marketed products including CMC variations, assessment of change control request for EU/US
• Deliver all project management activities to support the CMC post-approval work of the asset to ensure the necessary regulatory documents are delivered in time and with the adequate quality.
• Liaise with the Local Affiliates as needed to deliver efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
• Write, review and compile (as needed) all regulatory documents in support of each submission on time and in line with country requirements
• Generate gap analysis and risk management support for each submission as needed
• Management of all documents through the document management system

2. Regulatory intelligence

• Organize regulatory intelligence on EU and international texts and guidelines on specific area.

3. Pharmaceutical Responsibilities

• Participate to transverse project teams for pharmaceutical and industrial development: management of Out of Specification (OOS for production batches on stability), Product Quality Review (PQR), follow up of CMC commitments for the product under his/her responsibility.
• Provide status updates to all stakeholders as needed

• Pharmacist, Experienced 3 to 5 years
• Fluent in English
• Organized and independent
• Ability to manage multiple activities concomitantly