Senior Regulatory Affairs Manager

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story. 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 promote their personal growth 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 bold 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 an unparalleled, direct impact.

Job Title :
Senior Regulatory Affairs Manager Location :
Amsterdam - Netherlands

As the Regulatory Affairs (RA) Point of Contact for Galderma SA Netherlands (GSA NL), the Marketing Authorization Holder (MAH) for centrally authorized products and several EU countries, you will ensure MAH oversight of all regulatory activities for both EU-based entities and international activities, with a primary focus on pharmaceutical products and some oversight of cosmetic products. The role is part of the Global Regulatory function and includes acting as the Regulatory Affairs point of contact during Health Authority inspections.

You will conduct Regulatory Intelligence activities and leading selected initiatives, as well as managing service providers supporting the function, where applicable. You will also be in charge of Lifecycle Management (LCM) activities for pharmaceutical products.

MAH responsibilities maintain a global oversight with the different entities in the group to ensure MAH responsibilities from a PV / Quality and RA activities standpoint with main focus on pharmaceutical products ensure oversight of LCM activities and when GSA NL entity is used in development activities for pharmaceuticals (if applicable) be the point of contact for any regulatory assessment linked to this specific entity of GSA NL Branch be the point of contact for any Health Authority inspection and ensure the coordination of the preparation and the regulatory requests / sessions LCM activities for pharmaceuticals EMA contact point for centralized products in charge of LCM activities for pharmaceutical products with activities such as maintenance of licenses, coordination with Pharmacovigilance for safety variations, marketing and medical for labelling changes and RA CMC for quality variations activities include (but not limited to) regulatory strategy, dossier preparation (with regulatory review / input on core documents such as clinical overview), coordination of answer documents in case of HA questions, follow-up of the approval provide RA input if applicable in PV documents such as PBRER, DSUR and RMP ensure and update all regulatory databased (Regulatory Information Management System / Electronic…