Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist
Excellent opportunity for a Senior Regulatory Affairs Specialist to join a thriving company in Co. Galway .
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.

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