Regulatory Affairs Manager
Andy Leake at CK Clinical is recruiting for a Regulatory Affairs Manager to join a global pharmaceutical company at their site based in Slough, Berkshire on a 6-month contract basis.
Your main duties will be:
- Managing Clinical Trial Applications (CTA's) in EU for biologic products and provide operational regulatory support and guidance in cross-functional clinical trial teams (internal and external).
- Managing clinical trial submissions to agreed project targets, and overseeing the work of the assigned Contract Research Organization (CRO).
- Working flexibly within the EU team to provide broad operational for initial clinical trial applications, Q&A with Authorities/Ethics Committees, study maintenance, amendments, trial closure activities and archiving of trial documents.
Further responsibilities will include:
- Assisting in the planning, preparation and delivery for the delivery of timely Clinical Trial Applications and approvals.
- Providing regulatory expertise on clinical trial submissions.
- Ensuring that appropriate, up-to-date records are maintained for compliance.
The ideal candidate for this role will have:
- Proven experience performing coordinating, submitting and follow-up activities for CTA's in EU.
- Experience with biologic products.
- Inflammatory or Auto-Immune experience is a bonus.
- Effective communication skills.
- Ability to be flexible and adaptable.
For more information or to apply for this position, please contact Andy Leake on 01438 842 966 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47159 in all correspondence.