Benelux Head Regulatory, Medical Affairs and
il y a 1 semaine
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.
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.
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.
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 have the ability to create your own success. Galderma is growing and offers career growth and development potential.
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