Regulatory Affairs Project Manager

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