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 .
