Regulatory Affairs Manager
Regulatory Affairs Manager
Multiple Locations: Beerse, Belgium; Breda, Netherlands
Functions: Regulatory Affairs
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Requisition ID: 1905770239W
Regulatory Affairs Manager Benelux (2 positions available)
Location : Beerse (Belgium) or Breda (NL)
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a worldwide group of pharmaceutical companies, part of Johnson & Johnson, with more than 36.000 employees working on the five continents. Please visit www.janssen.com for more information.
Janssen Global Regulatory Affairs (GRA) is a critical strategic partner and core capability within Janssen. With more than 900 employees deployed in Europe, North America, the Middle East and Africa, GRA fosters relationship with Health Authorities around the world and delivers innovative healthcare solutions to patients. We help build and protect the reputation of our company in relation to compliance, quality, values and trustworthiness.
Janssen Benelux, with more than 200 employees located in Breda and Beerse, is responsible for more than 60 prescription medicines (> 1000 licenses). Janssen Benelux is recruiting for two Regulatory Affairs (RA) Managers Benelux. The RA Managers reports to the Head of RA Benelux, who reports to the Medical Director, member of the Benelux Management Board. The Benelux RA team, 9 FTE, is a strategic partner, core member of several internal (EVT, CVT) and external (pharma.be, VIG) cross-functional teams.
The Regulatory Affairs Manager is responsible for a broad range of regulatory activities for both new and core products in the Benelux. Depending on the candidate the role is to focus on new product introduction and/or life cycle management of the 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 (GRA). 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.
Key responsibilities (depending on candidate)
* Monitor new and revised regulatory requirements, assess the impact on the business and implement
* Inform internal stakeholders (local and regional) on new and revised regulatory requirements
* Translate environmental developments into relevant actions for EVT/CVT and other departments, enabling the business to optimize the strategy
* Drive local implementation of regulatory developments and update SOP/WIs accordingly
* Build and maintain positive relationships with local regulators and regulatory policy-makers
* Develop, roll out and maintain an external stakeholder management plan
* Comment on draft local/regional legislation and Health Authority guidelines (e.g. aRMM, compounding, e-leaflet)
* Prepare for, support and attend internal audits and external inspections
* Prepare for launch, including 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 EVT/CVTs and support EVT/CVTs with regulatory intelligence (early access programs, regulatory strategy, GMO legislation)
* 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 (CUPs, MNPs, aRMMs, DHPCs, withdrawals, stop commercialization, interruption of supply, MAH transfers, digital)
* Negotiate with local Health Authorities to reach the most optimal conditions of the registrations
* Review and approve local submissions coordinated by the EMEA Regulatory Management Center (SmPC updates, translations, artwork)
* Lead and/or participate in company multidisciplinary projects (e.g. e-leaflet)
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
* A high customer focus and awareness of the importance of business results
* The ability to innovate and to coordinate and drive a complex and changing environment
* A proactive, well organized and team player mindset
* 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 organization
* Fluent in English, French and/or Dutch (speaking, reading and writing)
* Small team lead experience is an advantage
Primary location: Belgium - Beerse and/or The Netherlands - Breda
What's in it for you…?
"Caring for the world, one person at a time…"
As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Europe/Middle East/Africa-Netherlands-North Brabant-Breda
Janssen Cilag N.V./S.A. (7025)