Overview

Reference Number: JO-2104-466398
Senior Director, Global Regulatory Affairs CMC
Rate: £100,000 – 120,000
Job Type: Permanent
Location: Dublin City Centre

Job Role: Senior Director, Global Regulatory Affairs CMC Biologics

Location: Ireland, Dublin, Cork, Waterford (Homeworking flexibility)

Salary: £100,000 – £120,000 plus bonus (Negotiable DOE)

CPL Life Sciences are now partnering with an established Pharma who are now looking for a Senior Director, Global Regulatory Affairs CMC Biologics, to join the team in Ireland. This comes as part of growth plans to further develop the core regulatory unit in Ireland.

The Senior Director will be responsible for leading all regulatory CMC activities across a licensed and development biologic portfolio and provide senior strategic leadership across early development, lifecycle maintenance and post-approval.

Responsibilities:

–         Lead a global Regulatory CMC Team

–         Develop and implement global regulatory CMC strategy

–         Support Global RA objectives

Experience:

–         10 years plus experience

–         Excellent knowledge of EMA and FDA regulations

–         Strong experience of Biologics CMC

–         Cell and Gene Therapy experience a plus

–         Manufacturing, QA/QC a plus

–         Strong leadership experience

To be considered for this role please apply with an updated version of your CV and I will be in touch to discuss further. 

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