Regulatory Affairs Executive

Key People


Job ID :

13954


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Maidenhead,Maidenhead,


Key Skills :

Regulatory, Variations, Submissions, NeeS/eCTD, Generics, MRP, DCP


Salary :

£35000 - £40000 per annum + benefits


Date Posted :

11 Jan, 2019



Company Name :

Key People


Location1 :

Maidenhead




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

A start up pharmaceutical client is looking for a Regulatory Affairs Executive on a permanent basis. The role is focused on submitting applications via NP and the ideal candidate would be responsible for mentoring junior regulatory team members as well as liaising with relevant regulatory authorities.

The role is based in Maidenhead and salary is paying up to £40,000.

As the Regulatory Affairs Executive you would be responsible for preparing and submitting applications in accordance with deadlines to MHRA via National Procedure.

The candidate would be implementing activities associated with variations, labelling changes, remediation dossiers and license transfers. There will be the need to communicate and liaise with regulatory authorities in gaining the approval of submissions.

In the position, you would look to mentor and provide training to junior team members. Maintenance associate with Marketing Authorisations as well as providing broader regulatory support across the company will form a key part of the role.

The desired candidate would plan and develop briefing documents for meeting with Regulatory Agencies. Providing input and reviewing the submissions documentation to ensure everything is fit for purpose will be an essential part of the position.

Developing protocols according to regional registration strategies will play a part in support of registration and labeling. As the Regulatory Executive you would need to make sure of completion of CTA submission packages according to timeline.

The client is seeking a Regulatory Executive to provide support across registration process, life cycle management and manage submissions in defining submission plans. You would need to advise team on necessary documents and strategy in preparation of MAAs.

For further information, please get in touch with Ross Wilson either at rwilson@keypeople.co.uk or on +44(0)1727 817621.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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