Regulatory Affairs Manager Benelux
Il y a 6 mois
Education : 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 our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.**
**Position Description**
The main purpose of this position is to contribute to the maintenance of existing and registration of new animal health products (veterinary medicinal products, feed additives, biocides and care products) through ensuring regulatory compliance and continuity of supply in accordance with business needs, directions and strategies in the European area with a special focus on Benelux.
This role works with various Elanco departments, such as other regulatory functions, pharmacovigilance, quality, supply chain, manufacturing, business as well as with external parties like health agencies, distributors, national institutes, etc.
**Functions, Duties, Tasks**
- Ensure compliance with regulatory requirements (timely submission of regulatory procedures including Variations, Renewals, Referrals) for existing and upcoming portfolio (Pharmaceuticals, Vaccines, Feed-Additives, Biocides)
- Update of the various regulatory Information management programs (e.g. Vault RIM/Pharao) and documentation repositories in agreement with regulatory management & internal procedures.
- Coordinate and/or conduct packaging development as part of ALRP responsibilities in Benelux, including release of production artwork in BLUE.
- Contribute to project forecast and prioritization and regulatory strategy in Benelux
- Provide leadership in the coordination of Benelux issues, submissions, packaging updates and other national tasks
- Regulatory review and approval of promotional materials in PromoMats
- Monitor regulatory environment including updates of national regulations and other European regulations/guidelines applicable locally
- Build and maintain good relationships with the Competent Authorities of Benelux countries, with a focus on established products
- Work effectively, efficiently and flexibly within and across all Elanco teams and external collaborators to achieve overall Elanco registration deliverables.
- Identify and utilize methods to deliver individual objectives in a high quality, timely, cost-effective manner.
- Provide information to facilitate accurate and timely project and budget forecasts
- Perform other regulatory related duties/assignments, support BeNeNo Team and lead BeNeNo Regulatory Affairs projects on a as needed basis when required by business and directed by management
**Minimum Qualification (education, experience and/or training, required certifications)**
- Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
- Good computer skills (Word, Excel, knowledge of data management)
- Excellent interpersonal and communication skills
- Strong attention to detail
- Good planning and organizational skills
- Fluent English language and Dutch language (written and verbal)
**Additional Preferences**
- Previous experience in hands-on working in regulatory affairs, ideally in a similar position
- Fluency in French (written and verbal) is an asset
- Open-mindedness and team player
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
-
Senior Regulatory Affairs Manager Benelux
Il y a 4 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...
-
Industrial Pharmacist
il y a 16 heures
Antwerpen, Belgique Air Liquide Temps plein**English** Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives. We are constantly inventing and developing solutions for healthcare facilities. In the Hospital Care (Belux) business, our employees serve more than 7,500...
-
Regulatory Affairs Lead Belux
il y a 1 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinFor 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...
-
Regulatory Affairs
Il y a 7 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...
-
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...
-
Svp, Global Regulatory and Public Affairs
Il y a 7 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...
-
Consultant Regulatory Affairs
il y a 3 jours
Antwerpen, Belgique Maandag Temps plein**Over de functie**: In jouw functie als Consultant Regulatory Affairs ben je verantwoordelijk voor de productieregistratie activiteiten van jouw producten. Je beheert de voltooiing van je projecten, beheert je eigen tijd om afgesproken doelen te bereiken. Je werkt samen met interne afdelingen, R&D en wereldwijde collega's om de introductie van nieuwe...
-
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...
-
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 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...
-
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 & 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...
-
Regulatory Compliance Officer
il y a 5 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 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...
-
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...
-
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...
-
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...
-
Associate Systems and Processes, Cmc Regulatory
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJanssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Global Regulatory Affairs - CMC. The preferred locations for this role are Beerse, Belgium, and Titusville, NJ. This role is primarily on-site with hybrid possibilities. At the Janssen Pharmaceutical Companies of Johnson & Johnson,...
-
Sales Manager Benelux
Il y a 7 mois
Antwerpen, Belgique Aures Temps plein**Organisatie omschrijving**: "Onze opdrachtgever is een toonaangevende speler in de ontwikkeling, productie en verkoop van transportoplossingen. Ze hebben een sterke focus op innovatie en streven ernaar om transportproducten te creëren die bijdragen aan een schonere en betere leefomgeving. Om de groei in de Benelux-regio te stimuleren zijn ze op zoek naae...
-
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...
