Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Excellent opportunity for a Senior Regulatory Affairs Specialist to join a thriving company in Co. Clare.
The Senior Regulatory Affairs Specialist for EMEA region will be responsible for all aspects of regulatory in the region, including but not limited to: ingredient review, marketing collateral review, product registrations, and label reviews.
The Regulatory Affairs Specialist will ensure compliance to and demonstrate knowledge of site and division-level policies and procedures.
Key Responsibilities :
- Responsible for regulatory activities of EMEA countries to launch and secure the products in the markets.
- Basic understanding of laws and regulations of the responsible EMEA countries.
- Assist the Head of Departments in responding to all product-related inquiries and actions by regulators and internal departments.
- Assist in preparing and filing necessary documentation for applications with international government agencies for product registration and coordinating advice on technical aspects of product labeling, product dossiers, claims substantiation/localization, and product registrations
- Review marketing materials for compliance with advertising law and scientific substantiation.
- Review product labels for compliance with local labeling regulations for medical devices, general wellness, supplements, and cosmetics.
Qualifications:
- Bachelor's degree in a relevant discipline
- Minimum 4 years of experience in regulatory affairs in medical device, cosmetic, food, or similar industry.
- Proficiency in Microsoft Suite required
- Strong attention to detail and time management skills
- Excellent communication skills, both written and oral
For further information please contact Loretta Flynn
[email protected]
086-1838380
INDPERM
