Benelux Head Regulatory, Medical Affairs and
il y a 1 mois
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients and the healthcare professionals we serve every day. We aim to empower each employee and to promote their personal growth all the while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create unparalleled, direct impact.
**Job Description**:
Galderma is looking for a
_Benelux H_
- ead Regulatory, Medical Affairs _
- and Compliance_
- _to lead and manage the registration process to ensure new products approvals, manufacturing permits, import permits and amendments (variations, 5-year renewal, post-approval commitments), Medical Affairs and Compliance for Galderma’s products in Benelux.
As the main contact for health authorities on regulatory and medical conditions you will manage all Benelux activities in Regulatory, Medical, Pharmacovigilance, Quality, Compliance & Publicity. Monitor Pharmaceutical laws in all 3 countries and ensure operational compliance (advertising, congress, packaging, samples, pharmaceutical SOP).
You will Lead the Benelux Regulatory, Medical, Pharmacovigilance, Quality, Compliance team.
Key Tasks- Design and direct regulatory and medical strategy for all products in the 3 countries in accordance with corporate strategy and collaborating with different functions.- In charge of interaction with Health Authorities and KOLs/ thought leaders in the 3 countries.- In charge of setting priorities, assuring resources, leading and developing a team of regulatory / scientific experts.- Ensure operational compliance with local regulations.- Responsible for compliance of HCP’s, publicity approval & market access dossiers- Designated as GDP Responsible Person (RP) for the Benelux. GDPR maintains an oversight of the storage and distribution of pharmaceutical products in compliance with the legal responsibilities
Skills & Qualifications- University Degree (scientific degree as Pharmacist is preferable or MD, Chemist).- Fluent in Dutch and English. French a plus.- Minimum 5 years previous experience in regulatory affairs/ medical affairs in pharmaceutical industry.- Good knowledge of healthcare system, good understanding of Pharmacoeconomics and pricing regulations.- Good knowledge of compliance for Health Care Professionals & Organization’s- Proven leadership and ability to set strategy and to manage a team.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
You will receive a competitive base salary plus an attractive bonus plan and other benefits.
You will have the ability to create your own success. Galderma is growing and offers career growth and development potential.
Nous avons d'autres emplois actuels liés à ce domaine que vous pouvez trouver ci-dessous
-
Regulatory Affairs Specialist – Medical Devices
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinQbD Belgium Regulatory affairs Table of Contents At QbD our RA Services go from regulatory strategy, clinical, technical file to Vigilance. We support from idea to commercialization. Do you want to support companies throughout the entire medical device regulatory lifecycle? Do you want to guide them through complex regulatory requirements? This...
-
Benelux Head Regulatory, Medical Affairs and
il y a 1 semaine
Antwerpen, Flandre, Belgique Galderma Temps pleinWith a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...
-
Associate Director Regulatory Affairs
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinRA Austria Regulatory affairs Table of Contents QbD Austria , part of the international QbD group, is a young and growing consulting company offering services and training on regulatory affairs, regulatory compliance, business organization and quality assurance in the pharmaceutical, food supplement and medical device industry. Our headquarters...
-
Regulatory Affairs Specialist – ATMP
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinQbD - Regulatory Affairs Specialist - ATMP in BelgiumTable of ContentsJoin our QbD team where Regulatory Affairs services cover regulatory strategy, CTD registration dossier writing, eCTD compilation, and submission to competent authorities, extending to Vigilance. We provide support from concept to commercialization. Are you passionate about ensuring...
-
Associate Medical Affairs Benelux
il y a 1 semaine
Antwerpen, Flandre, Belgique Kenvue Temps pleinAssociate Medical Affairs Benelux W Description Kenvue is currently recruiting for: Associate Medical Affairs Benelux This position reports to Associate Manager, Medical Affairs CE and is based at Antwerp, Belgium. Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science,...
-
Associate Director/Director Regulatory Affairs
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinRA The UK Regulatory affairs Table of Contents The UK team of the international QbD group, is a specialist regulatory and pharmacovigilance consultancy company. Our services consist in providing consultation throughout product development, regulatory approval, market launch, and into life cycle management. We have been offering support to life...
-
Regulatory Affairs Manager Benelux
il y a 1 semaine
Antwerpen, Flandre, Belgique Elanco Tiergesundheit AG Temps pleinRegulatory Affairs Manager Benelux page is loaded Regulatory Affairs Manager Benelux Apply locations BE - Antwerp time type Full time posted on Posted 30+ Days Ago job requisition id R 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...
-
Regulatory Affairs Manager Benelux
il y a 4 semaines
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...
-
Regulatory Affairs Manager Benelux
il y a 1 jour
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...
-
Regulatory Affairs Manager Benelux
il y a 1 semaine
Antwerpen, Flandre, Belgique Elanco Temps pleinEducation :EQUIVALENTEXPERIENCEAs 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...
-
Authorised Representative Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinQarad Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs...
-
RA Specialist China
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinRA Austria Regulatory affairs Table of Contents QbD Austria , part of the international QbD group, is a young and growing consulting company offering services and training on regulatory affairs, regulatory compliance, business organization and quality assurance in the pharmaceutical, food supplement and medical device industry. Our headquarters...
-
Senior Expert IVD
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinRA Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and...
-
Division Head – Regulatory Affairs
il y a 1 semaine
Antwerpen, Flandre, Belgique QBD Temps pleinRA Belgium, The Netherlands, The UK Table of Contents QbD's team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the entire regulatory...
-
Regulatory Affairs Manager
il y a 1 semaine
Antwerpen, Flandre, Belgique Flanders Temps pleinVacancyFlen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device markets. We have a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA. At Flen Health, we focus on people with topical inflammatory and...
-
Regulatory Affairs Specialist
il y a 2 semaines
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...
-
Emea Medical Affairs Director Hematology
il y a 1 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...
-
Expert IVD
il y a 1 semaine
Antwerpen, Flandre, Belgique Regulatory affairs Temps pleinQarad Belgium Regulatory affairs Table of Contents Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs...
-
Svp, Global Regulatory and Public Affairs
il y a 1 semaine
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...
-
Svp, Global Regulatory and Public Affairs
il y a 1 semaine
Antwerpen, Flandre, Belgique APWIP Belgium Temps pleinPrimary 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 maintain...
