Créée en 2013, IVIDATA Life Sciences est une société de conseil française spécialisée dans le domaine de la santé. Nos 160 consultants accompagnent des laboratoires pharmaceutiques, sociétés de biotechnologies, dispositifs médicaux, établissements de santé, cosmétique, nutrition et santé animale.
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
- Pharmacist, Experienced 3 to 5 years
- Fluent in English
- Organized and independent
- Ability to manage multiple activities concomitantly