Regulatory Affairs Manager

Reference Number: JO-2308-521058
Regulatory Affairs Manager
Rate: Negotiable
Job Type: Contract
Location: Crawley

Regulatory Affairs Manager

12 month contract

Remote Based – travel once a month to West Sussex

Offering attractive hourly rate PAYE DOE

CPL Life Sciences is collaborating with a leading biopharmaceutical organisation who are looking for a Regulatory Affairs Manager on an initial 12 month contract. Supporting the Head of Regulatory Affairs you will be responsible for preparing and maintaining national labelling and national submission requirements. Working across the UK/Ireland affiliate you will be supporting across 15 products across 2 main therapeutic areas.

Job Responsibilities include;

– Prepare and maintain national labelling (SmPC, PIL and labels)

– Prepare dossiers to meet national submission requirements for new licences, licence renewals, variations, PSURs and DSURs

– Maintain national aspects of global regulatory systems

– To maintain global regulatory systems and provide input as requested. To review global SOPs and assess their impact on local processes. To develop and maintain local systems and processes, including SOPs and checklists

– To maintain national distribution licences and participate in GDP inspections as required.

Candidate Requirements include;

– Eligibility to live and work in the United Kingdom

– Life Sciences degree or equivalent background

– Previous experience of UK and EU Regulatory Affairs

– Labelling preparation experience – including checking leaflets, packaging, SmPCs, print releases

– Good experience with different regulatory systems such as Veeva, packaging systems, submission systems

If this position is of interest please forward your up to date CV to Sophie on sophie.malyon@cpl.com.