Johnson & Johnson Loopbaan
Regulatory Affairs Therapeutic Area Expert Benelux
Requisition ID: 1805681247W
You will be the Regulatory Affairs Expert for a broad range of regulatory activities for both new and established products in the Benelux with core focus on Belgium and Luxembourg.
Janssen is looking for a talented, experienced regulatory affairs expert to join the Benelux Regulatory Affairs team. The role is to focus primarily on new product introduction and life cycle management of all Janssen prescription products. The successful candidate will be dedicated to a (set of) Therapeutic Area(s) and will work closely together with local and regional project teams.
The ideal candidate will bring in this role a high level of awareness of the Benelux regulatory environment, including central/MRP/national registration procedures, issue management and portfolio optimization. The candidate will require regulatory expertise and problem-solving capabilities that will enable successful development of local strategies and technical solutions to support the business. The candidate will have excellent interpersonal, negotiation and communication skills.
• Ensure marketing authorizations and updates are compliant with regulatory requirements for all registered Janssen products (CP, DCP/MRP, NP)
• Prepare for and manage local submissions, assuring timely execution and compliance (SmPC updates, CMC updates, translations, renewals, PSURs, RMPs, DHPCs, withdrawals, RMAs)
• Prepare for launch, including the local early access program strategy, in alignment with EMEA-RA, Medical, Market Access, Supply and Brand Value Management
• Ensure timely and pro-active communication of marketing authorization status and the impact to local Cluster Value Teams (CVTs) and support CVTs with regulatory intelligence (early access programs, regulatory strategy)
• Build and sustain positive relationships with local Health Authorities
• Keep abreast of the evolutions in regulatory legislation and assess the impact on the business
• Provide local regulatory requirements and intelligence to the EMEA-RA and GRA organization
Education and experience
• University degree – medical or paramedical (pharmacy, biology, veterinary, etc.) or equivalent by experience
• Regulatory experience in drug development and commercialization
• Knowledge of BE/LU pharmaceutical legislation and experience with EU regulatory procedures
• Experience in working in cross-functional project teams and/or a matrix organization
• Excellent oral and written communication skills
• The ability to work successfully within a collaborative team environment and as an individual contributor and decision maker within a cross-functional remote organization
• Fluent in English, French and Dutch (speaking, reading and writing); basic understanding of German
• Small team lead experience is an advantage
Janssen Cilag N.V./S.A. (7025)