Job Reference: 1602-2
Job Duration:
Start date: a.s.a.p
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
*Maintaincurrent knowledge of regulatory affairs legislation
*Ensure all regulatory databases are kept up to date
*Provide support formarketing material
2. Pharmacovigilance
*Ensure pharmacovigilance activities performed are completed in a timely manner, andin 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 atimely 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 20years. 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.
Industry: Pharmaceuticals
Salary: £35000 - £40000 per annum + bonus and benefits
Salary Benefits: bonus and benefits
Vacancy Type: Permanent
Job Skills: regulatory affairs, officer,associate, europe, registrations and post approval, generics, labelling, PV, Quality
Contact Name: Tim Barratt
Website: -
Direct Application URL: -