Johnson & Johnson Careers
Regulatory Affairs Lead Belgium/Luxembourg
Requisition ID: 1805689519W
You will be the responsible for the regulatory activities, all regulatory external relations and a small team in Belgium and Luxembourg.
Janssen is looking for a talented, experienced regulatory affairs lead 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 candidate will be the External Regulatory Lead in Belgium and Luxembourg will have a few direct reports.
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)
Represent the company in regulatory trade association and 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
Lead a small team of regulatory experts/professionals
Education and experience
University degree – medical or paramedical (pharmacy, biology, veterinary, etc.) or equivalent by experience
8 or more years of experience in RA, at least 3 years of experience in TA Expert or External lead role, including proven experience with people management
Big picture view of the regulatory role in the pharmaceutical industry
Knowledge of BE/LU pharmaceutical legislation and experience with EU regulatory procedures
Very strong interpersonal and communication skills; able to influence without authority
Able 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
Janssen Cilag N.V./S.A. (7025)