An exciting opportunity within a leader global CRO for a Regulatory Affairs Manager to join their expanding Clinical Study Start-Up and Regulatory Affairs group. This is a full-time position based in the UK.
- Effectively and rapidly coordinate & manage CTA submissions to regulatory authorities and ethics committees and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
- Ensure high quality performance of deliverables are applied within the projects assigned and promptly identify and address any risk/potential risk by implementing preventive measures
- Provide regulatory strategic advice to internal and external customers
- Contribute towards the preparation and/or review of technical documentation (i.e. protocol, IMPDs and IBs) when required
- Review and, if applicable, customise all relevant documentation (i.e. labels, patient information sheets, diary cards, insurance etc) to ensure high level of quality and compliance with ICH GCP & country specific requirements
- Assist RA-BIDs and senior management in securing new business or repeated business by participating to BDMs, developing/ reviewing regulatory sections of proposals and regulatory costing and budgets
- Provide coaching, advice and mentoring to regulatory members assigned to the projects (although the position will not have any direct line management responsibilities)
SKILLS AND EXPERIENCE:
- Bachelor's Degree in Chemistry or Life Sciences.
- At least 5 years within pharmaceutical/CRO industry.
- Ability to successfully manage global projects
- Excellent ability to handle multiple tasks in a fast-paced environment
- Expert knowledge of drug development
- Expert knowledge of ICH GCP and the EU Clinical Trials Directive/Regulation and
- National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)
In return for meeting the above criteria, the successful candidate will be rewarded with a very competitive basic salary.
Elevate Pharma is a specialist Life Sciences Recruiter and this vacancy is just one of a number of positions that we currently have available in this sector.