Senior Regulatory Affairs Manager

galderma; Amsterdam; On-site; EUR 90,000 - 130,000; Full time

Job summary

Galderma in Amsterdam, Netherlands, is seeking a Senior Regulatory Affairs Manager to lead EU regulatory strategy and MAH oversight for pharmaceutical products. You will coordinate HA inspections, manage LCM activities and ensure alignment with EMA requirements across global entities.

The role requires deep expertise in regulatory affairs, dossier preparation, and regulatory intelligence to support compliant submissions and lifecycle management in a fast-evolving European landscape.

Responsibilities

• MAH responsibilities: maintain global oversight with group entities for PV/QA/RA for pharmaceutical products
• Regulatory strategy and dossier preparation, including core documents like clinical overview
• Coordinate responses to HA questions and manage HA inspections
• Lead LCM activities and coordinate with EMA for centralized products
• Maintain regulatory databases (RIMS/EDMS) and perform regulatory intelligence in EU focus
• Ensure compliance with new EU pharma laws and related regulatory changes
• Collaborate with Regulatory Service Providers to improve processes

Job description

About Galderma

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 Details

Job Title : Senior Regulatory Affairs Manager

Location : Amsterdam - Netherlands

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 impro