Overview

Reference Number: JO-2107-471745
Regulatory Associate Director
Rate: Negotiable
Job Type: Permanent
Location: Uxbridge

Regulatory Affairs Associate Director

Location: Middlesex & offering 2/3 days home-working

Salary: Offering highly competitive salary & package dependant on experience

Permanent position

Reference: JO-2107-471745

CPL Life Sciences are collaborating with a rapidly expanding biopharmaceutical company to hire an experienced & scientific regulatory professional who can take lead on interactions with EU agencies. In this role you will be responsible for supporting drug development activities & managing a team, leading MAA processes to ensure timely product approval.

Responsibilities include

Lead, manage and develop EU regulatory team members

Co-ordinate and execute CTAs for assigned programs

Collaborate with cross-functional teams to develop EU strategies

Monitor emerging legislation and guidance in the EU and ensure any emerging issues are flagged

Deal with EMA interactions, scientific advice, orphan designation, PIPs

Requirements

Must have a relevant life sciences degree

Experience working with rare diseases, gene therapies or monoclonal antibodies would be highly advantageous

Extensive experience interacting with EMA

Proven ability to track & support EU CTAs

Experienced bringing a product to approval in EU would be highly advantageous

If you would like to apply for this position or discuss our other active positions please contact Charlie on 01189 522 797 or Charlie.Harris@cpl.com .