Overview

Reference Number: JO-2104-466508
Senior Manager Global Regulatory Affairs Biologics
Rate: £65,000 – 85,000
Job Type: Permanent
Location: Dublin City Centre

Job Title: Senior Manager, Global Regulatory Affairs CMC Biologics

Location: Ireland, United Kingdom, Dublin, Cork, Waterford (homebased with travel to sites in Ireland)

Salary: 65,000 – 85,000 plus bonus and benefits (Negotiable depending on experience)

CPL are now partnering with an established global pharma to grow the core regulatory team who are based out of the offices in Ireland. This is an exciting to join a growing team working across developing and licensed products within some innovative therapeutic areas.

The Senior Manager will work in a global capacity, leading CMC and product strategy for a Biologics portfolio and will lead on CMC regulatory activities for a biologics portfolio with products at marketed and development stage.

Role:

– Responsible for regulatory strategy ensuring it aligns with FDA/EMA regulations

– Collaborate with global cross functional teams

– Lead lifecycle maintenance

– Responsible for new submissions including preparation, submitting and review for dossiers

– Team mentoring/management responsibility

Experience:

– Must have strong understand of EMA and FDA regulations

– Biologics product experience

– Extensive CMC regulatory experience

– ATMP experience would be a plus