Regulatory Affairs Project Lead H/F
www.servier.com
Accountable for leading regulatory submission activities covering whole product lifecycle (from FIH to license withdrawal) for the product or product family is in charge of :
- Member of the Global regulatory Team, coordinating all activities relating to management of submission.
- Support Global Regulatory Lead (GRL) while building submission plan and annual regulatory roadmap. Responsible for generating and follow-up of the timetables (e.g. commitments, renewals). Provide dashboard for steering the regulatory activity to the GRL and Global Regulatory Team.
- Responsible for compiling the reference dossier (M2 to M5) in close collaboration with the GRL and Regulatory CMC : producing e-CTD backbone structure of the reference dossier, and identifying owners and timing for each deliverable.
- Responsible for the planning of the dossier preparation WW on the basis of reference dossier, in close collaboration with RRL/local regulatory managers who provide the local requirements and adapt the TOC of the core dossier.
Manage the dossier preparation and follow the submission
- Responsible for dossier building :
- Creating table of content based on reference dossier and local requirements provided by Regional Regulatory leads
- Setting up dossier according to the local TOC, consolidate specific local format/technical requirements
- Coordinate the collection of the documents related to the dossier preparation for submission (e.g. integrate CMC part to the dossier)
- Liaise with publishing service provider for dispatch to markets and informs regional leads and GRL
- Ensure the follow up of the dispatch and submission with the support of the external vendor and LRA if applicable
- Responsible for updating dossier and core reference according to identified needs (e.g. new data, new requirements, questions for Agencies)
- Oversight of the regulatory databases. Define and trigger QC and monitoring action in collaboration with System Business Expert. Follow CAPA
KPI responsibilities and interactions
- Meeting pre-agreed submission milestones for products, the submission manager coordinates or flagging as early as possible when he becomes aware of slipping timelines.
- Is member of the Global Regulatory Team.
- Key interfaces outside Regulatory Affairs : Medical Writing, Therapeutic Areas and R&D Operations, Translational Medicines, Clinical development, Industry.
Responsibilities :
- Accountable for planning and execution of the dossier filing for product(s)
- Lead the dossier preparation and compilation, coordinate and manage the interaction with service providers in charge of publishing
- Responsible for the filing in due dates.
Profile :
- Minimum of 3 years' experience in managing regulatory process and registration aspects.
- Experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development.
- Understanding of and ability to determine relevance of regulatory processes and regulations.
- Comfortable with IT tools and e-submission format.
- Project management experience and ability to work independently.
- Experience of leading the coordinating of preparation of high-quality submissions to regulatory agencies for clinical trial and marketing approval within project timelines.
- Excellent communication skills, organization and planning skills and attention to detail.
- Must BE able to communicate effectively in the English language.
Quel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.
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