Regulatory Affairs Manager - Essex - European Role

Key People


Job ID :

7060


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Essex,Essex,


Key Skills :

Regulatory Affairs Manager , Manager , Officer , Regulatory Senior Manager , principle officer


Salary :

£40000 - £45000 per annum + Bonus and Benifits


Date Posted :

04 May, 2017



Company Name :

Key People


Location1 :

Essex




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

A full time permanent position has arisen within European Regulatory Affairs.
You must be able to perform the necessary regulatory tasks; registration strategy, dossier compilation, data and documentation review, submission execution, evaluation review Ensure high quality data and standards are used in support of all regulatory applications to achieve rapid and successful assessment.
*Track and monitor queries/deficiency letters/commitments from/to Regulatory Agency to ensure these are implemented and conformed to, timely.
*Develop and maintain thorough and up-to-date understanding of the EU regulatory environment.
*Provide regulatory support to project teams, stakeholders and customers, as required.
*Guide other RA colleagues and COREx counterparts to continually improve and grow in both technical and soft skills needed for RA work in PGT environment.
*Identify process gaps in the RA operations and institute the necessary processes (SOPs, WIs) for remediation and improvement.


Main Responsibilities;
*Lead the registration process for new Marketing Authorisation Applications
*Provide initial and final regulatory strategies in accordance with COREx processes
*Contribute to strategic decisions requiring regulatory input to minimise risks
*Lead the maintenance work on launch critical post-approval variations for authorised products
*Provide central RA support to countries and regions
*Provide RA support to new initiatives
*Identify needs for new SOPs / WIs to improve processes



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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