Regulatory Affairs Lead BeLux
il y a 3 semaines
Description
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.
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.g. 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.
- 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.
- 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.
- 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.
#J-18808-Ljbffr-
Sr. Government Affairs Manager Belux
il y a 3 jours
Brussels, Belgique British American Tobacco Temps plein. **BAT is evolving at pace - truly like no other organisation.** **To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!** **BAT BELGIUM IS LOOKING FOR A SENIOR GOVERNMENT AFFAIRS MANAGER BELUX** **SENIORITY LEVEL**:Senior Management **FUNCTION**:...
-
Quality & Regulatory Affairs Manager – Belgium
il y a 3 semaines
Brussels, Belgique Inizio Engage Temps pleinAre you ready to take your expertise in Quality & Regulatory Affairs to the next level in a fast-growing healthcare company? Our client is looking for a passionate professional to lead quality management, regulatory compliance, and pharmacovigilance in Belgium. Join a dynamic and innovative team where your skills will have a direct impact on the safety and...
-
Regulatory Affairs Administrator
il y a 3 jours
Brussels, Belgique EORTC Temps pleinThe Regulatory Affairs Administrator works under the hierarchical supervision of the Head of Regulatory Affairs Department (RAD). **Main responsibilities / Major Activities**: - Works under supervision and in close collaboration with the RAM - Sets the administrative frame for adequate filing and tracking of the RAD responsibilities - Set-up and maintains...
-
Regulatory Scientific Affairs Manager
il y a 7 jours
Brussels, Belgique Nestlé Temps plein**Position Summary** The Regulatory Scientific Affairs (RSA) Lead role will be key in building and strengthening connections and trust at all levels of the hierarchy both internally and externally. This includes building relationships with Authorities, NGOs, Universities, Industry, and interest groups to create a robust external network. Additionally, the...
-
Regulatory Affairs Officer
il y a 3 semaines
Brussels, Belgique Company EG NVSA Temps plein**About EG** EG is the largest pharmaceutical company in Belgium. With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies. We still produce many of our medicines and food supplements in Belgium. We currently have 180 employees and continue to invest in: - The...
-
Regulatory Affairs Officer
il y a 1 semaine
Brussels, Belgique STADA Arzneimittel AG Temps plein**About EG** - EG is the largest pharmaceutical company in Belgium.- With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- We still produce many of our medicines and food supplements in Belgium. We currently have 180 employees and continue to invest in: - The...
-
Manager, Lead for Regulatory Affairs Europe
il y a 2 semaines
Brussels, Belgique Plasma Protein Therapeutics Association Temps pleinThe Manager, Lead for Regulatory Affairs, Europe, will be a key team player working in a matrix with other PPTA staff to manage the regulatory and scientific affairs activities primarily in Europe. The manager will be responsible for evaluating and reporting on industry issues of a regulatory and scientific nature. This includes monitoring, evaluating, and...
-
Regulatory Affairs Manager, Brussels
il y a 4 semaines
Brussels, Belgique TN Belgium Temps pleinSocial network you want to login/join with:EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.EG is also the largest pharmaceutical company in Belgium. With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in...
-
Regulatory Affairs Specialist
il y a 3 jours
Brussels, Belgique Amaris Consulting Temps plein**Who are we? **:**Amaris Consulting** is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7,600 people spread across 5 continents and more than 60...
-
Regulatory Affairs Officer
il y a 1 semaine
Brussels, Belgique Meet Recruitment Temps plein60000 EUR - 60000 EUR - Liege, Belgium - Permanent **Regulatory Affairs Officer - Small Pharma - Hybrid - Belgium** Really pleased to be able to bring a new, exciting Women's Health Vacancy to the market. I am collaborating with my Client, a small pharma based in Belgium to support them in their search for an experienced Regulatory Affairs Officer to join...
-
Regulatory Affairs Liaison Oncology
il y a 4 jours
Brussels, Belgique MSD Temps pleinDo you want to be part of our Oncology division, helping people fight cancer, supporting accessibility to our cancer medicines, and pursuing research in immuno-oncology to bring new hope to people with cancer? We have a new, exciting opportunity for a **Regulatory Affairs Liaison Oncology (Associate Principal Scientist) **to be based in Oss (NL), Brussels...
-
Regulatory Affairs Specialist
il y a 1 semaine
Brussels, Belgique Luminus Temps pleinAls Junior Regulatory Affairs Manager maak je deel uit van de **Corporate Affairs** afdeling. De afdeling Corporate Affairs staat centraal in de relaties van Luminus met overheden, toezichthouders en besluitvormers. Het departement vergemakkelijkt de uitwisselingen tussen deze instellingen en de operationele activiteiten van Luminus, dient als interface om...
-
Eu Public Affairs Lead
il y a 1 semaine
Brussels, Belgique Takeda Pharmaceutical Temps pleinAre you looking for a patient-focused innovation-driven company who will support your career and future? Join us as EU Public Affairs Lead in Brussels, Belgium! Objectives: - Drive policy discussions in the EU (Brussels) and Europe on the value of plasma and the need for a supportive policy and regulatory environment to enable reliable access to plasma and...
-
Head of Quality and Regulatory Affairs
il y a 2 jours
Brussels, Belgique SASMAR Temps pleinSASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and fertility...
-
Senior Advisor Rapa Regulatory Authorities
il y a 5 jours
Brussels, Belgique ELECTRABEL Temps pleinIdentifiant de la demande: 1839- Lieu de travail: Brussel, BE, 1000For our Regulatory Authorities & Public Affairs (RAPA) team Belux, we are looking for a: **Senior Advisor RAPA** **Mission** - RAPA (Regulatory Authorities & Public Affairs) Belux_ is responsible for devising the vision and strategy in respect of the regulatory and public affairs activities...
-
International Corporate Affairs Lead
il y a 3 jours
Brussels, Belgique Proximus Group Temps pleinA job at Proximus? You’ll find that everything revolves around the idea ‘Think Possible’. This means: we always assume that something is possible, even if it seems impossible. Well, especially so, actually. Call it a way of thinking that involves being open to a world of digital solutions that make our lives easier. And our way of working...
-
Regulatory Affairs/site Activation Manager
il y a 4 jours
Brussels, Belgique Oxford Global Resources Temps plein**Regulatory Affairs/Site Activation Manager**: - Location: Brussels, Belgium - Contact: Amandine Planche - Job type: Contract - Contact phone: +32 10 68 53 34 - Industry: Life Sciences, Clinical Research For one of our client located in the East of Brussels, we are looking for an experienced Regulatory Affairs/Site Activation Manager. Hybrid working...
-
Senior Advisor Rapa Regulatory Authorities
il y a 5 jours
Brussels, Belgique ELECTRABEL Temps pleinID vacature aanvraag: 1839- Standplaats: Brussel, BE, 1000For our Regulatory Authorities & Public Affairs (RAPA) team Belux, we are looking for a: **Senior Advisor RAPA** **Mission** - RAPA (Regulatory Authorities & Public Affairs) Belux_ is responsible for devising the vision and strategy in respect of the regulatory and public affairs activities for Engie...
-
Regulatory Affairs Manager Benelux
il y a 3 jours
Brussels, Belgique Grünenthal Temps plein**Country**:Belgium**City**:Brussels**Department**:Research & Development**Job ID**:43270**Hiring Manager**: Mirjam van de Wiel- If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In - **Research & Development**, we’re continuously exploring innovative new treatment options to make a stronger,...
-
Consultant in Political and Public Affairs
il y a 1 semaine
Brussels, Belgique FairValue Corporate & Public Affairs Temps pleinJOB OFFER (Brussels): Consultant in Political and Public Affairs ** Bilingual French - English** **Fairvalue Corporate & Public Affairs is an independent European consultancy specialising in global corporate strategy, public and political affairs, corporate communications, crisis management and international business development. The firm has a small team...
