Regulatory Officer, Central London

Key People

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Job ID :

8695


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

regulatory affairs, officer, associate, europe, registrations and post approval, generics, labelling


Salary :

£35000 - £40000 per annum + bonus and benefits


Date Posted :

13 Sep, 2017



Company Name :

Key People


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for a Regulatory Officer to join a Pharmaceutical company based in central London. Within this role you will be responsible for registering an exciting range of new products and maintaining a European Portfolio. This role has become available due to an ongoing period of growth within the company and your responsibilities will be split across Regulatory, PV and Quality.

Responsibilities include:
*Ensure regulatory submission (DCP's, MRP's and National applications) are completed in a timely manner using eCTD
*Perform routine regulatory activities (i.e. maintenance/renewals, variations, 61(3) notifications)
*Aid in technical input where required
*Ensure artworks are created and approved in time for product launches
*Maintain current knowledge of regulatory affairs legislation
*Ensure all regulatory databases are kept up to date
*Provide support for marketing material

2. Pharmacovigilance
*Ensure pharmacovigilance activities performed are completed in a timely manner, and in accordance with pharmacovigilance legislation
*Ensure PSUR's are submitted in accordance with agreed schedules
*Maintain effective dialogue with pharmacovigilance contract providers
*Ensure regulatory changes to product information are provided in a timely manner to the pharmacovigilance contract provider and all relevant departments

3. Quality Assurance
*Prepare and maintain Product Compliance Files
*Review of validation documents
*Ensure Quality systems are maintained
*Ensure retained samples are stored in accordance with SOP
*Prepare/review SOP's where required

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

Key People is a recruitment consultancy with a reputation for providing good value that's been built up over 20 years. Clients come to us for three main reasons:

> We achieve results faster
> Our candidates really are a cut above
> We add greater value

We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide, throughout Europe and also many around the globe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career. And, as we work for 75% of FTSE 100 companies, you'll get the chance to work for some prestigious, blue-chip organisations.


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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