Regulatory Affairs Associate

Location
Berkshire, England
Salary
£20000 - £25000 per annum
Posted
14 Oct 2019
Closes
11 Nov 2019
Ref
23979
Contact
Ross Wilson
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Entry level
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 rwilson@keypeople.co.uk

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