Senior legal counsel - Regulatory law EMEA

Senior legal counsel - Regulatory law EMEA
Regio: Diegem
Vereiste ervaring: 5 jaar
Werkomgeving: Onderneming
Ref: LexGO04/05
Contract: Onbepaalde duur (Voltijds)


"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products, and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

The Johnson & Johnson Global Legal Organization is recruiting a Senior Regulatory Legal Counsel to provide regulatory legal support to its businesses in EMEA. The position will support sustainability issues and our pharmaceutical business. The position will be based preferably in Belgium (Diegem or Beerse); other central European locations such as France, The Netherlands, UK, Switzerland and Germany may be considered for the right talent.

We are looking for a candidate with a Law degree (Master), minimum 5 years of regulatory legal experience in the pharmaceutical / life sciences sector and excellent written / spoken English.

We seek a new colleague passionate about uncharted legal territories and healthcare; eager to collaborate with diverse legal and business partners ; and who will bring a phenomenal energy to our work and team!

Job responsibilities

The role will provide regulatory legal support primarily to two main client groups:

  • Sustainability matters both for J&J’s Pharmaceutical sector and MedTech sector in EMEA, and
  • the J&J pharmaceutical sector business across the EMEA region

In both areas you will be dealing with sophisticated, novel and varied regulatory legal issues.

Your scope of work will include

  • Provide expert legal advice on Sustainability matters to both Pharmaceutical and Medtech clients and at enterprise level, including on REACH and other (envisaged) EU Sustainability legislations and initiatives such as on Green Claims, Microplastics Restrictions, Eco-design, EU Packaging and Packaging Waste, chemicals strategy for sustainability, environmental aspects of the Pharmaceutical Strategy.
  • Provide expert legal advice to pharmaceutical business in EMEA, including Integrated Brand Value Teams and Compound Development Teams, working closely together with various functional groups on regulatory legal matters across the region, notably Regulatory Affairs, Quality, Medical Affairs, Medical Safety, Governmental Affairs & Policy, Health Care Compliance, Communication, and of course other legal colleagues. Focus of this support will be on:
  • Regulatory legal advice to support compliant and competitive clinical development, regulatory, marketing, medical information, market access and patient engagement activities in the region with respect to innovative medicinal products.
  • MA / Regulatory strategy incl. filing pathways and regulatory exclusivities; orphan and paediatric regimes; compliance in specialized markets.
  • Strengthening regulatory legal expertise in these areas as well as in personalized medicines/advanced therapy medicinal products.
  • Flexibility to support also other Therapeutic Areas and assets/activities of J&J in EMEA, in particular where alignments exist, and other assigned areas.
  • Close collaboration with other Legal colleagues as well as Government Affairs & Policy, Regulatory Policy group, Regional Sustainability and Product Stewardship groups and other internal and external partners on policy and advocacy matters in particular with respect to the evolving European Pharmaceuticals’ framework, Sustainability/ESG and EU Green Deal. Further building up on the internal and external networks in this space.

You will be part of the broader EMEA Legal team and the global J&J Global Legal Organization. The role will report to a Legal Director, Regulatory Law EMEA.


About the candidate:

  • You have a Law degree (Master). A supplementary degree or LLM is considered an asset.
  • You are able to express yourself fluently in English (both written and orally); other languages are considered an asset.
  • You have minimum 5 years of proven experience  in regulatory legal work in the life sciences industry, acquired in:
    • an international law firm, international consultancy firm or trade association,
    • and/or legal department of an international corporation in the healthcare industry.
  • You either have experience with regulatory legal support of medicinal products or with Sustainability matters in the life sciences industry, preferably both.
  • Experience with personalized medicines, advanced therapy medicinal products and companion diagnostics are considered an asset.
  • Experience with REACH is considered an asset.
  • Prior experience working in a cross-functional virtual international environment is considered an asset.
  • You can work in a team and communicate with diverse partners , have an analytical and pragmatic attitude , are ethic-driven, and can operate with a certain level of autonomy.
  • You are able to travel up to 10% of the time.

This is what awaits you at J&J

  • An opportunity to be part of a global market leader
  • A dynamic and inspiring working environment
  • Many opportunities to work on challenging projects and assignments
  • Possibilities for further personal as well as professional development
  • Many employees benefits

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Apply now!

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