Regulatory Affairs Specialist
About the Role:
* Spearhead all regulatory affairs activities for medicinal products and medical devices on the Irish market, ensuring seamless integration with business objectives.
* Oversee assigned regulatory projects, launches, and initiatives for the Irish market, guaranteeing timely and compliant execution.
* Maintain stringent adherence to regulations, laws, and industry policies affecting company products, upholding the highest standards of quality and compliance.
* Support the lifecycle management of product licenses, coordinating submissions and approvals in alignment with HQ strategies.
* Ensure high-quality, compliant labelling for all marketed products, driving customer satisfaction through accurate product representation.
Key Requirements:
* Holds a 3rd level qualification, preferably in Life Sciences.
* Demonstrates pharmaceutical industry experience.
* Possesses expertise in Regulatory Affairs, with a proven track record of delivering results.