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.
nj.
om/.
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, ensuring proper use of systems (e.
.
CRM system) and monitor if processes are executed according to applicable SOPs.
Ensuring compliance with company policies and SOPs (Standard Operating Procedures).
Developing and monitoring metrics in relation to regulatory affairs to inform performance, efficiency, resourcing needs, etc… Encouraging a culture of Cross-functional teamwork Ensure active representation of the regulatory department as key partner within the CVT with continuous engagement and support.
Building a continuous communication process with other functions on LOC and regional level, as well as ensuring collaboration with other countries as appropriate (special emphasis on collaboration with The Netherlands) Lead/participate in strategic and operational regulatory projects for portfolio optimization striving to improve the internal processes and collaboration with other internal collaborators.
Qualifications Functional skills required A university (Master) degree or equivalent experience in pharmaceutical/medical related science.
The preferred candidate will have a Master degree or equivalent experience in science, pharmacy or medicine.
A solid experience within the pharmaceutical business environment (min 8 years) with a multi-year experience in team leadership role(s) including a thorough knowledge and understanding of regulatory requirements, HA regulations & guidelines in Belgium & Luxembourg Shown ability and track record in functioning in a matrix environment, needing to build collaboration and partnerships across functions/groups.
High level of verbal and written communication skills, including effective listening and the ability to speak and write persuasively.
Good active knowledge in English, Dutch and French.
Intellectual curiosity, critical thinking, self-awareness, and adaptability.
Ability to interact with senior management and senior representatives of external collaborators in a clear and concise manner and ability to argument, negotiate and obtain consensus.
Ability to work collaboratively and establish positive working relationships with industry, health authority and internal collaborators.
Personal characteristics.
Strong leadership capability High level of energy, enthusiasm, sense of urgency and ambition.
Positive and proactive “make things happen” attitude.
Challenge the status quo.
Agility to navigate and demonstrate sophisticated organizations and situations Passion for innovation and for turning obstacles into opportunities.
High ethical standards.
Excellent active knowledge of English, Dutch and French 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, national origin, disability status, or any other characteristic protected by law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.