Regulatory Affairs Associate

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,Berkshire,Berkshire,

Key Skills :

Regulatory Affairs, Post Approval, Generics, Post Approval, Solid Dosage

Salary :

£20000 - £25000 per annum

Date Posted :

14 Oct, 2019

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



My client, a generics pharmaceutical company in the Berkshire area, is looking for a Regulatory Affairs Associate on a permanent basis. This will be paying upwards of £20,000 plus benefits.

General Responsibilities include but are not limited to:

*Help prepare and submit applications of reliable quality in a timely manner to 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

*Partake in the interfacing with regulatory authorities to facilitate the approval of submissions
*Stay informed about new and changing regulatory requirements and ensuring compliance
*Liaise with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome

Required Skills
*Pharmacy/Chemistry degree
*Ideally 1 years of Regulatory Affairs experience with a focus on Post Approval activities
*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.

Additional Experience
*Attention to detail and able to produce quality documentation
*Good interpersonal skills
*Effective oral and written communication skills
*Excellent organizational and planning skills
*Ability to work independently
*Ability to interpret data and draw meaningful conclusions

If the above is of interest, you are eligible and believe yourself to have a suitable profile, please apply and get in touch with Ross Wilson at

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




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.

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