Senior cmc reg consultant small molecules life cycle h/f

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. Nos expertises s'articulent autour de 5 domaines majeurs : Biométrie, Opérations cliniques, Affaires réglementaires, Vigilances, Assurance Qualité. Senior CMC Reg Consultant (Small Molecules Lifecycle).

Mission :

To lead and deliver the post-approval activities across all global markets for commercial small molecule products.

Activities and responsibilities :
- Lead the CMC Regulatory strategy for all post-approval activities of the asset, providing proactive and timely advice to the technical team.
- Manage and deliver all regulatory aspects related to Change Control requests
- Lead and 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 develop efficient regulatory strategies to deliver the CMC Dossier in line with country requirements and agreed timelines
- Represent CMC Regulatory across the relevant governance meetings and activities
- 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
- Identify rate limiting deliverables and interdependencies across the technical and regulatory aspects of the different submissions
- Provide status updates to all stakeholders as needed
- Management of all documents through the document management system

Profile/Experience :
- > 10 year experience in CMC technical roles with at least 5 years working on lifecycle management of small molecule products
- Extensive experience in managing the delivery of post-approval CMC Regulatory activities for small molecules assets globally.
- Proven track record of effective stakeholder management across the lifecycle activities of assets
- Organized and independent
- Ability to manage multiple activities concomitantly
- Degree in Pharmacy or a relevant science/technical subject
- Fluent in English