Reg Affairs Associate

2 weeks ago

Galway, Ireland Cpl Full time

Regulatory Affairs Associate

Coordinate and manage regulatory submissions and compliance activities across multiple departments, ensuring alignment with international regulatory standards. Support audits, inspections, and product lifecycle submissions to achieve timely approvals.

Responsibilities:

Coordinate and prepare regulatory document packages for submissions, audits, and inspections.Compile and lead submission activities for new applications, license renewals, and annual registrations.Recommend updates to labeling, manufacturing processes, marketing materials, and clinical protocols for regulatory compliance.Maintain and improve systems for tracking and controlling regulatory documentation.Stay current with evolving regulatory requirements and procedures.May engage directly with regulatory authorities on defined topics.Develop strategies to support the earliest possible approval of clinical trial applications.

Requirements:

Level 8 university degree in a relevant scientific or technical discipline.1–2 years of relevant experience, ideally in a regulated industry such as pharmaceuticals or medical devices.

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