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Regulatory Affairs Manager

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Company Profile Merial Animal Health Ltd
Merial Animal Health Ltd
Job ID Number 44298
Job Title Regulatory Affairs Manager
Job Location Harlow, Essex
Apply Ring Michelle on her direct line 01494 818 024 or you can apply online:

Job Description Job title: Regulatory Affairs Manager
Reports to ( title ) : Head of Regulatory Affairs UK and Ireland
Department / Area : Regulatory Affairs

Essential information on the position includes, but is not limited to:
Purpose
The active management of Marketing Authorisations in UK and Ireland including obtaining, maintaining and renewing, in order to legally permit the company to place its products on the market.

Major responsibilities
" To anticipate and proactively take the appropriate regulatory actions to obtain, maintain and extend Marketing Authorisations in UK & Ireland, (including renewals, variations and new applications) under the guidance of the Head of Regulatory Affairs in close collaboration with Regional RA and other departments, and taking account of local business priorities
" Timely preparation of submissions to regulatory authorities including data compilation, argumentation, to required standards
" Timely processing and onward submission of dossiers and submissions prepared by Regional RA
" Proactive direct liaison with local regulatory authorities including Veterinary Medicines Directorate, Irish Medicines Board and other governmental/regulatory authorities whose activities impact on the veterinary medicines market. (
" Provide accurate and up-to-date advice on regulatory issues to local colleagues in business and other functions, and regarding local RA specifics to Regional RA and other functions
" Ensure that Merial promotional activities in UK and Ireland are consistent with the MAs, local regulations and codes of practice
" Ensure that Merial product packaging and datasheets in UK and Ireland are updated for consistency with the MAs and regulations
" Assist with UK batch release process, if required

Person Profile Knowledge and skills
" Scientific background to degree level, preferably some experience of regulatory affairs or similar in veterinary or related field, organised approach with attention detail, flexibility, integrity, ability to meet deadlines, good communication and interpersonal skills
Job Package TBC
Interview Process TBC
 

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Michelle
Account Manager
for this opportunity

01494 818 024
(Mon to Fri 0830 to 1800 hours)
michelle@zenopa.com

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