Regulatory Clinical Trial application Associate - 362403

CK Group are recruiting for a Clinical Trial Application contractor to join a biopharmaceutical company at their site based in Welwyn Garden City, Hertfordshire on a contract basis for 12 months. This role has been determined as Outside IR35, and youcan join on a PAYE basis via CK, or Ltd/umbrella company option.

Location:

This Regulatory CTA contractor position will ideally be based from the client's office (when this is permitted) in Welwyn Garden City. There will be a degree of home working allowed and could be fully remote for an experienced candidate. The office in Welwyn Garden City is easily reached from the A1/M1 and is 25 minutes by train from Kings Cross.

Salary: A Daily rate is on offer :

• 200-£300 per day (Ltd/Umbrella company - does not include holiday pay)
• 152 - £228 per day (PAYE, includes 25 days + 8 BH paid leave)

As a Regulatory Clinical Trial Application contractor your responsibilities will be to:

• Actively manage the UK CTAs of assigned products to the MHRA.
• Creating the initial packages and submitting to the MHRA and lifecycle maintenance such as substantial amendments and end of trial notifications.
• Assess technical/scientific content of proposed CTA submissions to meet MHRA requirements.
• Proposes solutions to correct deficiencies.
• Experience of liaising with the MHRA to discuss any Regulatory Clinical Trial issues.

Your Background:

• Must have at least 2 years Regulatory affairs experience, preferably within theUK
• Prior experience dealing with MHRA
• Experience of clinical trial application submissions
• Any experience of CWOW (combined ways of working) would be beneficial

Apply:

For more information or to apply for this Regulatory CTA contractorposition, please contact Steve Lord on 01246 457733 or email slord@ckgroup.co.uk. 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 CL52603 in all correspondence.