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Regulatory Affairs Specialist
2 months ago
Galderma is a leading dermatology company with a presence in approximately 90 countries. We are seeking a highly skilled Senior Regulatory Affairs Specialist to drive local Regulatory Affairs priorities for medicinal products in the UK and Ireland.
Key Responsibilities:- Develop and execute regulatory strategies to obtain timely approvals by MHRA and HPRA.
- Lead new Marketing Authorisation Applications (MAAs) for UK and Ireland, compiling local dossier parts.
- Ensure compliance with existing product licenses through submissions of variations, renewals, and safety updates.
- Support the launch of new products by collaborating with Marketing/Commercial, Supply Chain, and other stakeholders.
- Review and approve promotional and non-promotional materials, ensuring compliance with local regulations.
- Manage in-house regulatory files, documentation, and Corporate electronic databases.
- Contribute regulatory expertise in local health authority/GxP inspections.
- Strong understanding and hands-on experience with medicinal products (POM, P & OTC) at local affiliate level for UK and Ireland.
- Experience with cosmetics beneficial.
- In-depth understanding of the pharmaceutical industry across the UK and Ireland.
- Significant know-how of the post-Brexit regulatory environment.
- Fluency in English (excellent written and spoken).
As a Senior Regulatory Affairs Specialist at Galderma, you will have the opportunity to shape the regulatory landscape and drive business growth. If you are a motivated and experienced professional with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.