Laurent Lefebvre Email & Phone Number

Saint-Louis, Grand Est, Fr

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

1. Formulate, lead and drive regional and/or global CMC regulatory strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance2. Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg CMC, DRA, TechOps and TRD as appropriate.3. Lead and implement all regional CMC submission activities (planning, review, coordination, submission) for assigned projects/products, while applying the global strategy into regional submissions.4. Establish and maintain a single point of contact with FDA or CPOs, DRA EGM, DRA Latam and DRA TA for all communication on development and marketed products. Establish and maintain sound working relationships with partners and customers.5. Initiate and lead regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals.6. Lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate.7. Lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions for communication and action planning with subteams.8. Represent Reg CMC, and therefore provide input to licensing decisions, on due diligence and divestment teams.9. Represent Reg CMC on teams for continuous improvement within the department.10. Provide leadership within the department within specialized matrix functions.11. Act as mentor/coach to new members of Reg CMC; act as coach to all Reg CMC members in areas of expertise.

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Basel, Baselstadt, Ch

Support on various project of the Marketed Product units. Filling of variations in Europe and Rest of the World, writing of CMC regulatory documentation, Reg-Intel support, database compliance and filling...

Mutagenesis, protein extraction and purification, protein analyzis, bioproduction.

Docteur En Pharmacie, Pharmacie

Docteur En Pharmacie, Pharmacie