Senior Regulatory Affairs Manager
Galderma
Senior Regulatory Affairs Manager
Galderma is seeking a Senior Regulatory Affairs Manager in Amsterdam to act as the Regulatory Affairs Point of Contact for Galderma SA Netherlands, ensuring MAH oversight of regulatory activities for pharmaceutical products. The role involves lifecycle management, regulatory intelligence, and managing service providers, requiring 10 years of experience in Regulatory Affairs and fluency in English and Dutch.
Senior Regulatory Affairs Manager
Galderma is seeking a Senior Regulatory Affairs Manager in Amsterdam to act as the Regulatory Affairs Point of Contact for Galderma SA Netherlands, ensuring MAH oversight of regulatory activities for pharmaceutical products. The role involves lifecycle management, regulatory intelligence, and managing service providers, requiring 10 years of experience in Regulatory Affairs and fluency in English and Dutch.
Salary
Core Qualifications
Technical (Must-have)
Soft Skills
Key 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
- 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 ...)
- 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
- Provides input to maintain and improve processes with regulatory service providers for the activities if applicable
- 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