Sr Regulatory Affairs Manager Benelux
Regulatory Affairs Manager Benelux (m/f/x, 100%)
At Janssen, we are dedicated to addressing and solving some of the most significant unmet medical needs of our time in hematology, oncology, immunology, neuroscience, infectious diseases and vaccines, rare diseases, and cardiovascular and metabolic diseases. Motivated by our dedication to patients, we bring innovative products, services, and solutions to people all over the world.
We are now recruiting a Regulatory Affairs Manager for Janssen-Cilag. Regulatory Affairs is a key partner within the business, involved in many projects and decisions across the company. We seek to become more strategic and externally focused. To achieve this goal, we are looking for a person who will combine (i) Therapeutic Area (TA) responsibility with (ii) being External Regulatory Lead for BE/LU and (iii) back-up of the Regulatory Affairs Head. The position reports into the Head of Benelux Regulatory Affairs. The position can be in either Beerse, Belgium or Breda, The Netherlands. It is an office-based position with limited travelling.
At Janssen, we have a strong belief in stimulating growth of our talents. We make this happen by creating a personalized development plan, with the aim to continue your development and enhance performance. Job responsibilities
The responsibilities of the Regulatory Affairs Manager are very diverse and will include, among others:
Therapeutic Area Regulatory Affairs
- Represent Regulatory Affairs in Benelux cross-functional Value Teams, working closely with Commercial, Market Access, Medical Affairs, Legal, Commercial Quality, Medical Safety, Governmental Affairs & Policy and others.
- Lead and coordinate assigned activities within the Value Teams and other functions, such as product readiness for launch, implementation of risk-minimization activities and product issue management.
- Ensure the Value Teams are up to date with product regulatory status, updates and plans, enabling local strategy optimization.
- Translate environment developments into relevant actions for the Value Teams, enabling an optimized strategy.
- Keep overview of all regulatory-related activities for the assigned therapeutic area, such as supervising implementation of procedures, compliance, intelligence. Centralized products only, no MRP/NP.
- Operational contacts with Health Authorities.
- Perform all required product tasks, following plan and updates from Regulatory head office, enabling efficient label implementation and maintenance.
- Ensure that, where any local issues are identified as potentially impacting regulatory strategy, these are highlighted to Regulatory head office to ensure that the regulatory strategy can be implemented efficiently.
- Ensure efficient compliance to local, regional and Janssen regulations, to minimize risk for the patients and Janssen business
External Regulatory Lead BE/LU
- Influence and shape the external environment applying a long-term strategy
- Being active in regulatory workgroups in local trade associations
- Build relations with regulators and policy makers, bringing the Janssen opinion to the discussion / negotiating where possible
- Be 100% up to date with all relevant developments in the regulatory environment and translate these developments into relevant actions for our business
- Assess the impact of legislation changes on the business and ensure organization readiness to address them proactively
Back up of the Head of Regulatory Affairs Benelux
QualificationsWhat you will need to succeed
- Take over managerial tasks of the RA Head Benelux, if applicable
- Participate in the cross functional Compliance SteerCo (Legal, Commercial Quality, Medical Safety, Privacy, Health Care Compliance, Information & Publicity)
- Be the line-manager of the RA Specialist, if applicable
We are looking for a dedicated RA leader with passion for the industry and interest in growth and development.
- A minimum of a bachelor’s degree in Life Science (required). A degree in Pharmacy (preferred).
- A minimum of eight years of experience of Regulatory Affairs in the Pharmaceutical Industry, Health Authorities or equivalent (required).
- Experience of working in Regulatory Affairs in a head office and/or cross-functionally in a local marketing company (preferred).
- A minimum of two years of experience in Health Authority relationship management (required) and an active role in a local trade association (preferred).
- Knowledge of the EU regulatory framework and the way it is implemented in the Benelux countries (required).
- Experience in a variety of Regulatory Affairs tasks such as working with centralized approved products and dealing with local implementation of Risk Management Plans. Involved in launches of new products (required).
- Excellent in building a network and communicating with Health Authorities. You understand the regulatory legislative processes and impact and can influence (required).
- Languages (required):
- Native language (Dutch or French) with fluent active knowledge of other national language
- English: excellent professional knowledge
The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.Primary Location
Janssen Cilag N.V./S.A. (7025)Job Function
Regulatory AffairsRequisition ID
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