Regulatory Affairs

I am currently recruiting for a number of senior Regulatory Affairs roles for clients situated in the Dublin area.

Senior Regulatory Team Lead – Global Pharmaceutical Company

Main Objectives of The Role:

• Working within an environment with an international outlook, manage the team of Regulatory Affairs Officers and submissions process for MRP/DCP procedures, achieving long term account goals in line with the company vision and values.
• Managing and overseeing the coordination of regulatory submissions assigned to RA International Submissions Team and ensuring registration deadlines are met.

Requirements:

• Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree.
• Min 4-5 year experience in a regulatory affairs environment in the pharmaceutical industry preferably.
• Detailed knowledge of EU current registration requirements for dossier preparation and procedure running.

Regulatory Affairs Officer - Medical Device Company

Main Objectives of The Role:

• Supporting Global Regulatory Affairs with national regulatory information and advice as required.
• Ensuring all medicinal product registrations are current and marketed in full compliance with their approved registration files.
• Providing input to the global regulatory affairs databases to ensure up-to-date status regarding national regulatory activities.
• Preparation, submission, and follow-up of medicinal product applications, as required and directed, to the HPRA and associated liaison with Global Regulatory Affairs.

Requirements:

• A 3rd level science qualification.
• Approx 1-3 year’s work experience in a compliance environment.
• Knowledge of EU and national regulatory requirements.

For  full job specs and to apply for these roles, please call Ciara on +353 1 2784671 or email cnugent@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com