Regulatory Affairs Executive

Key People

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Job ID :

15068


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Berkshire,Berkshire,


Key Skills :

regulatory, executive, officer, senior officer, regulatory associate, berkshire


Salary :

£35000 - £40000 per annum + benefits


Date Posted :

01 Jul, 2019



Company Name :

Key People


Location1 :

Berkshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An exciting opportunity has become available for an experienced and enthusiastic Regulatory Affairs Executive / Senior Regulatory Officer, to join an exciting new client based in Berkshire! The successful candidate will have a strong background in registration and post approval submissions, and ideally a background within generics.

Responsibilities:
*Prepare and submit applications to the MHRA (UK) via National Procedure. These include new licence applications, variations (including grouping and work sharing), renewals, artwork changes, RFIs, updates and any other relevant applications or notifications.
*Have a good understanding of and be able to execute activities related to the following key areas
oVariations: Type 1A, 1B, II, Labelling changes including own label supplies, safety updates and line extensions
oReclassification of Medicines
oRe-baseline / Remediation dossiers
oLicense Transfers (giving away and bringing in) including the due diligence of dossiers
oMaintenance of Marketing Authorisations including renewals
oDeficiency responses to authorities
*Partake in the interfacing with regulatory authorities to facilitate the approval of submissions
*Act as a point of contact for other business units, customers, and internal/external teams
*Assist the RA Manager in coaching and mentoring junior members of the team
*Maintain up-to-date records and documentation in relation to Marketing Authorisations.
*Carry out duties in line with regulatory, commercial, quality and business needs and ensure compliance with regulatory legislation, guidelines, and company processes and procedures.
*Assist in preparation of procedures for relevant regulatory activities, and in preparation and review of procedures for other areas.

Required Skills:
*Pharmacy/Chemistry degree
*2-3 years Regulatory Affairs experience
*Understanding of the current UK and European regulations, laws, guidelines and industry requirements.
*Exposure to NeeS/eCTD format and electronic submission gateways is preferable.
*Experience with Generic products and MRP/DCP submissions is advantageous.

For further details about this role, or other vacancies within Regulatory Affairs, please call Tim Barratt on +44(0)1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk


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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