Greater Mulhouse Area
Industrial Pharmacist with a broad experience in Drug Regulatory Affairs, having worked in the QC/QA area in different manufacturing sites, in DRA in a local affiliate company as well as in DRA and REG CMC at Headquarters in Big Pharma
. Lead the ISO IDMP Project for Novartis Pharma, with involvement of related Line functions (Regulatory, Drug Safety, Development and Technical Line Functions) . Ensure IDMP data model is introduced in newly developed IT projects (e.g. RIMS, Change Control Management system) . Ensure regular communication of project status within and outside the company . Active contribution in the review of the ISO IDMP implementation guidelines . Member of the SNV (Swiss representative) to ISO Technical Committee 215 WG 6 concerning ISO IDMP as of Jan-2016.
. Provide guidance and regulatory expertise to DRA organization in establishing and reviewing procedures to assure sustained compliance with HA regulations and internal Novartis policies (e.g. Pediatric Plans, Risk Management Plans, HA Post approval commitments) for the global Novartis portfolio . Expert in DRA systems and related tools supporting Health Registration Management processes worldwide (e.g. DRA Compliance system, system owner for the Pediatric Plan Tracker and the Health Authority requests Tracker) in order to provide guidance and training to associates worldwide . Collaborate with other Line functions (e.g. Regulatory CMC, Labeling, Drug Safety & Epidemiology) to optimize compliance and share information. Lead the DRA Compliance system User forum with involved partners . Gives input, evaluate, and if appropriate, implement systems enhancement requests in collaboration with business owner and IT . Contributes to the continuous development and monitoring of metrics related to Health Registration Management and Compliance Reporting to drive consistent quality . Represent DRA PIE in relation to HA registration processes and systems during inspections and audits in partnership with functional areas experts . Participates as an active contributor to related business process change and technology initiatives within DRA and across Development
. Provide and drive strategic and operational global CMC regulatory direction and documentation for products of the Integrated Hospital Care (IHC) (Jan-May 2012) and Established Medicines Franchises (since May 2012) covering development and post-approval activities . Lead global CMC regulatory strategy and submission activities for assigned development projects or marketed products in interactions with DRA at global and local levels . Lead and drive cross-functional CMC Health Authority Response Teams (HARTs) for assigned products, and prepare CMC responses as appropriate . Ensure the maintenance of consistency and quality in dossiers delivered and communication of lessons learned and trends within and outside the department (e.g. Liaison forums, group meetings, mentoring of new associates) . Co-lead of the REG-CMC Training network, develop and maintain oversight of training certifications, collaborate with Networks, Forums, and Expert Panels to identify training gaps and provide support to training owners/trainers
TECHNICAL AND REGULATORY AFFAIRS ACTIVITIES / HEAD PHARMACIST DEPUTY . Handle pharmaceutical questions and quality complaints (160 marketed products) . Update and sign-off for packaging elements in compliance with Mas . Evaluate and submit CMC variations to the French Agency.
. Sampling, Physico-chemical analysis on API/excipients (250 ref.), bulk and finished products (150 ref.), API and excipients release . QA activities supervision (SOPs, re-organization of the laboratories) . Mechanical and physical/chemical tests on all packaging elements (800 ref.) and suppliers’ audits . Assistance to Production Dept. and validation of new packaging elements (production transfers).
100 pharmaceutical dossiers (30 new products) . Quality control (chemical/microbiological) and batch release incl. Third party manufacturing . Management of site quality index including self-inspections
PHARMACEUTICAL RESPONSABILITIES ON SITE & TRAINING CORRESPONDANT . Batch release for distribution in France/Export territories (pharmacies, wholesalers, hospitals) . GMPs management on site (800 ref.) incl. training coordinator and stocks inventories.