Excellent opportunity for a Senior Regulatory Affairs Specialist to join a global team in supporting regulatory compliance for the EMEA region including South Africa and Australia. The Senior Regulatory Affairs specialist will report to the Associate Director of Regulatory and will be responsible for working with regulatory bodies, especially around labeling, for new products being introduced into these regions.
Overview of your responsibilities (full job description available on request)
- Manage regulatory activities across EMEA markets to support launches and maintain approvals.
- Keep up to date with regulations in assigned EMEA countries.
- Support the Head of Department with regulatory authorities, product, and internal queries.
- Prepare and submit product registration documents to authorities.
- Coordinate reviews of labels, dossiers, claims, and localization needs.
- Review marketing materials for legal and scientific compliance.
- Review labels for compliance across medical devices, wellness, supplements, and cosmetics.
Knowledge, Skills and Experience Required for the Role:
- Bachelor’s degree in Business or related field, or 4–6 years’ EMEA regulatory affairs experience.
- Background in medical devices, cosmetics, food, or supplements.
- Contract manufacturing experience is a plus.
- Proficient in Microsoft Office.
- Strong attention to detail and time management.
- Excellent written and verbal communication skills.
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
