Regulatory Affairs Lead BeLux

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

For our Local Operating Company in Belgium & Luxembourg, we are currently recruiting for a Regulatory Affairs Lead role based in our Beerse or Diegem office.

In this role you will be leading our Regulatory Affairs responsibilities, leading a team of experienced regulatory Affairs professionals.

This role is an excellent opportunity for experienced RA professionals with desire to lead and mentor a strong team of experts in Belgium.
Principal Activities

Lead the regulatory activities for Belgium and Luxembourg:

You are responsible for the oversight of the Marketing Authorization Holder's regulatory responsibilities and activities for Johnson & Johnson Innovative Medicines in Belgium and Luxembourg, such as submissions/approval of new MAAs, Renewals, LCM and other RA activities.

Besides this, you will lead the Regulatory team and be an important representative for JNJ towards the regulatory authorities in both countries.

As an ambassador for our company, you will be participating in and driving the external debate on regulatory affairs, within our industry association as well as relevant health authority collaborators.
Lead a regulatory team of expert Regulatory Affairs professionals


* Providing strategic and Business RA input to our internal Regulatory Affairs organization as well as the local Leadership Team of the Operating Company


* Monitoring legislative frameworks as well as industry guidance in relation to Regulatory Affairs


* Coordinating and leading the preparation of JNJ internal and Belux Health Authority audits in relation to the MA Regulatory Affairs responsibilities, and participate in business quality, pharmacovigilance, HCC or other functional audits where regulatory processes are in scope


* Ensuring collaboration and alignment with the internal Commercial/Medical leaders for the different therapeutic areas


* People leadership towards a team of regulatory affairs professionals ensuring proper training, daily coaching and performance management and talent development.


* Advancing career development through an integrated talent planning and management cycle that enables a targeted and pro-active approach to attract, develop, and retain a diverse and inclusive team with regulatory affairs technical, scientific, and leadership capabilities.


* Developing plans, processes, and SOP's (whenever appropriate) to optimize the creation and delivery of regulatory affairs activities, ensu...