Regulatory Affairs Officer

Key People

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Job ID :

7031


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Midlands,East Midlands,


Key Skills :

regulatory affairs, CMC, generics, associate, regulatory, post approval, EU, registrations


Salary :

£30000 - £35000 per annum + bonus and benefits


Date Posted :

02 May, 2017



Company Name :

Key People


Location1 :

East Midlands




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for a Regulatory Officer with 1-3 years of experience to join a leading Pharmaceutical company based in East Anglia.

Main Responsibilities:

- To manage post approval activities on a defined group of nationally approved products
- Review, compile and submit high quality regulatory submission packages to the UK MHRA and other EU Regulatory agencies where applicable.
- To work closely with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high quality regulatory documentation in accordance with UK requirements, legislation, guidance, and company procedures.
- To work closely with EU RA Competence Centres in order to provide timely UK specific documentation and/or information in support of EU new submissions and/or variations and renewals.
- To identify, initiate and prioritise areas for process improvement, and manage change as required.
- To ensure that all activities fully comply with Departmental and Company SOPs & Work Instructions.
- To ensure that all internal tracking tools and electronic databases are maintained, accurate and complete.
- To represent UK Regulatory Affairs in cross functional teams
- To understand and communicate complex issues to other Regulatory, Quality, Supply Chain, Product Management Medical, Pharmacovigilance, EPD and Senior Management colleagues.

Experience Required:
To be considered for these regulatory positions you should be educated to degree level in Life Sciences (or equivalent) along with significant experience within EU or UK Regulatory Affairs. You should have a good standard of technical knowledge, whilst CMC experience is desirable.


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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