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