Job Description

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

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 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.

Key Responsibilities:

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 Data Management System ...)

Regulatory Intelligence

• monitor internal and professional communications concerning relevant regulations (ICH, EMA, …) and perform regulatory intelligence activities with a focus on European regulation including all the requirements linked to the database and new ways of submitting changes - prepare the gap analysis for the coming new EU pharma law
• from the identified changes in the process of this new EU pharm, lead the overall process update within Global Regulatory Affairs (GRA)
• perform the impact analysis of transverse regulations such as the Packaging and Packaging Waste Regulation (PPWR) and propose action plans in close collaboration with affiliates
• prepare ad-hoc summaries and communication tools to inform relevant stakeholders / management

Management

• Regulatory Service Providers
• provides input to maintain and improve processes with regulatory service providers for the activities if applicable

Quality

• ensures that all regulatory documents are prepared and tracked in EDMS and that all regulatory activities are tracked in the regulatory affairs database
• Initiates, reviews and contribute to SOPs, forms, etc. to support regulatory development processes.
• contributes to improvements to processes and to ensure continued compliance with applicable regulations

Skills & Qualifications

• Scientific degree (BSc, MSc, PhD) or Pharmacist qualification
• 10 years of experience in Regulatory Affairs, including Lifecycle Management activities for centrally authorized products and Health Authority inspections
• Experience managing outsourced Regulatory Dossier activities and international projects
• Ability to deliver results effectively in a fast-paced environment with tight deadlines
• Experience interacting with regulatory agencies and contributing to global regulatory strategies
• Strong cross-functional collaboration skills, with the ability to influence and motivate teams
• Proven transversal leadership skills
• Excellent organizational, planning, analytical, and problem-solving skills
• Ability to identify opportunities and critical issues, assess impact, and communicate effectively
• Adaptability to changing priorities and dynamic environments
• Excellent verbal and written communication skills
• Fluent in English and Dutch

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.

Our people make a difference

At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.