Regulatory Affairs Project Manager

CPL

TIPPERARY

On behalf of our client, we are currently recruiting for a Regulatory Affairs Project Manager for a maternity contract cover role. This role can be based in the office in Munster, or there are flexible arrangements around being home based etc. Responsibilities of the CMC Project Manager: Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies. Review the preparation of CMC components for filings and assess fitness of purpose for submission in the relevant countries. Gathering, consolidating and analyzing regulatory intelligence for the EU & ROW territories and support its application to product-specific activities. Ownership/ regulatory responsibility for a portfolio of products for nominated client; via a range of regulatory activities including submission of new marketing authorization applications, variation applications and renewals. Work with the Managing Director and Project Manager to ensure that client deadlines are met and that appropriate resources are allocated to the various projects. Maintain communication with client and company teams to ensure that projects are delivered in keeping with our responsibilities to the client. Builds and maintains strong relationships with EU competent authorities to ensure ease of access & influence. Maintain an awareness of new and developing legislation, regulatory policy and technical guidance relating to the company's products. Supports EU regulatory initiatives and issues as appropriate. Knowledge and Skills. BSc (MSc or higher preferred) life sciences, or related field. 7-10 years related experience within Pharmaceutical Regulatory Affairs. Experience with global legislation and regulations relating to medicinal product registration. Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, line extensions and renewals. Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage. Ability to project manage across a diverse and complex portfolio of products and priorities. For a full Job Spec and to apply for this role please call Linda on +353 1 2784671 or e-mail ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671.

1684 days ago