Regulatory Affairs Lead Belux
il y a 1 mois
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.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
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 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 w
-
Svp, Global Regulatory and Public Affairs
Il y a 6 mois
Antwerpen, Belgique APWIP Belgium Temps plein**Primary Responsibilities**: - Develop and execute a global regulatory and public affairs strategy aligned with business objectives and growth plans, that includes, government affairs and public relations. - Lead government lobbying efforts to advocate for favorable regulatory environments that align with the company's goals and objectives. - Establish and...
-
Regulatory Affairs Consultant
il y a 1 mois
Antwerpen, Belgique Flanders.bio Temps pleinBen jij een ervaren Regulatory Affairs Specialist met een passie voor het waarborgen van naleving van regelgeving binnen de life sciences industrie? Wij zijn op zoek naar getalenteerde professionals die onze organisatie kunnen vertegenwoordigen bij bedrijven in ons Randstad netwerk in Antwerpen en Kempen. Als Regulatory Affairs Specialist in Life Sciences...
-
Regulatory Affairs Specialist
Il y a 7 mois
Antwerpen, Belgique Science Talents Temps plein**Introductie**: One of our clients based in Mechelen, active in pharma consulting of specialized services for the pharmaceutical, biotech and medical device industries, is looking for a regulatory affairs specialist. **Jobomschrijving**: - Obtain & maintain perfect knowledge of applicable legislation - Stay up to date with scientific developments relevant...
-
Senior Regulatory Affairs Manager Benelux
Il y a 3 mois
Antwerpen, Belgique Elanco Temps pleinEducation : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...
-
Regulatory Affairs Manager Benelux
Il y a 6 mois
Antwerpen, Belgique Elanco Temps pleinEducation : EQUIVALENTEXPERIENCE **As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance...
-
Cmc Regulatory Affairs Senior Associate
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Innovative Medicine is recruiting for CMC Regulatory Affairs Senior Associate. This role is located in Beerse, Belgium, and is primarily on-site with hybrid possibilities. At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most...
-
Regulatory Affairs
Il y a 6 mois
Antwerpen, Belgique Science Talents Temps plein**Introduction**: The vision of our client is to be the most responsible animal health company where employees, experts, partners and customers create togheter customizes animal health solutions for a better planet. Currently they are looking for a Regulatory Affairs & Quality Manager. The main purpose of this position is to contribute to the local...
-
Emea Medical Affairs Director Hematology
Il y a 8 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson is currently seeking an EMEA Medical Affairs Director Hematology to join our EMEA Strategy & Operations organisation. **Responsibilities**: To develop the EMEA Medical Strategy and the EMEA Medical Affairs Product Plan (MAP Plan) for Ciltacabtagene Autoleucel and Talquetamab in line with Global strategy and in alignment with the Integrated...
-
Regulatory Affairs Manager
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for Manager, Regulatory Affairs to support the initiatives for the Interventional Oncology group (INTO). The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor. **Key...
-
Medical Information Lead
il y a 1 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinFor our Local Operating Company in Belgium & Luxembourg, we are currently recruiting for a Medical Information Leader based in our Beerse or Diegem office. In this role you will be leading our Medical Information responsibilities and activities, leading a team of medical information professionals. This role is an excellent opportunity for experienced medical...
-
Regulatory & QA Officer
Il y a 4 mois
Antwerpen, Belgique Science Talents Temps plein**Introductie**: Met meer als 30 jaar ervaring in de registratie van diergeneesmiddelen op nationaal en internationaal niveau is onze klant een vaste waarde in de farmaceutische sector. Je komt terecht in een ervaren team dat al verschillende nationale, gedecentraliseerde (DCP) en gecentraliseerde (CP) procedures heeft afgerond. Deze leuke bende collega's is...
-
Associate Regulatory Site Officer
Il y a 8 mois
Antwerpen, Belgique MindCapture Temps pleinASSOCIATE REGULATORY SITE OFFICER - Pharma- AntwerpWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and resourcefulness in achieving success. We reward you with competitive salaries and offer a strong package of additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...
-
Regulatory Compliance Officer
il y a 2 jours
Antwerpen, Belgique NonStop Consulting Temps pleinAre you experienced in the field of SDS and CLP/GHS regulation? Are you looking for a new opportunity to work in a dynamic company and an exciting industry that offers great job security and career progression? We are currently working with a client located in the region of Antwerp that is looking for a newcomer to join in their very active compliance and...
-
Associate Director Regulatory Process Development
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps plein**Johnson & Johnson Innovative Medicine, is recruiting for an Associate Director, Regulatory Process Development (RPD).** The position can be located in Beerse, Belgium; Leiden, Netherlands; High Wycombe, UK; Raritan, NJ; Titusville, NJ; and Horsham, PA. **Responsibilities**: - Support the global regulatory process strategy that aligns with overall...
-
Marketing Lead
il y a 1 mois
Antwerpen, Belgique Dnrltd Temps pleinLocation: Our client is a global multinational drinks company with a portfolio of some of the world's best known brands. Job Description: We want ambitious, passionate people who live our brand and want to push themselves further. Ideally, you'll have several years of experience working within a marketing environment and a decent understanding of guerrilla...
-
Junior Eu Public Affairs Manager
Il y a 7 mois
Antwerpen, Belgique Knauf Insulation Western Europe Temps pleinKnauf stands for opportunity. We know that opportunity looks different to each person, and we are proud that we see opportunity in everyone. This exciting role in the Public Affairs team of Knauf Insulation could be the perfect next opportunity for you to build a unique career, in a values-led culture with a clear purpose of making tomorrow a home for all of...
-
Veterinary Regulatory and Quality Officer
il y a 2 semaines
Antwerpen, Belgique Science Talents Temps plein**Introductie**: - For our client, a veterinary medicines and feeds company we are looking for a Veterinary Regulatory and Quality officer. Check this great opportunity! **Jobomschrijving**: **Pharmacovigilance** - Adverse events/ complaints/ reports of veterinary medicinal and non-pharmaceutical products - Scientific support to the local contact person...
-
Manager, Global Labeling Product Leader
Il y a 4 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Labeling Product Leader in Raritan, NJ; Titusville, NJ; Horsham, PA; Toronto, Ontario (CA); UK (High Wycombe); Netherlands (Leiden); Belgium (Beerse); Allschwil, Bern, Zug (Switzerland) Our company thrives on a diverse company...
-
Business Unit Director Specialty Care Belux
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThe Business Unit Director is responsible for the P&L, strategy development and execution for business in BeLux for Specialty Care. You are responsible for portfolio management and for overseeing resource allocation and headcount consequences of business plans and a member of the Janssen BeLux Management Board and other relevant regional commercial networks...
-
Legal & Regulatory Specialist
il y a 4 semaines
Antwerpen, Belgique Legal Staffing Experts NV Temps pleinLegal Staffing Experts is op zoek naar een Legal & Regulatory Specialist voor haar klant in Gent. Waar ga je werken? Onze klant is een pionier in de energietransitie. Met elektriciteit uit 100% hernieuwbare bronnen en een sterke maatschappelijke betrokkenheid, inspireert onze klant anderen door te laten zien dat een duurzame toekomst technisch én...
