Job Reference: 1606-75
Job Duration:
Start date: a.s.a.p
Description:
An excellent opportunity has arisen for a Regulatory Affairs Officer to join a Hertfordshire based client within their exciting and fast moving team. The ideal person will have a strong background in EU regulatory and with a minimum of 18 months of industry regulatory exposure.
Responsibilities:
*Ensure suitable dossiers (new submissions, variations, and response to questions) areprepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission fromthird parties and provide advice regarding any deficiencies or issues
*Ensure databases and systems (including MyPortfolio andTrackWise) are updated in-line with current SOPs and up-to-date information for all assigned products
*Liaise with third parties to establish effective communication and relationships in order to progress regulatory activities
*Active involvement in duediligence activities including dossier audits, evaluation of regulatory strategy and launch timelines, evaluation of risks andregulatory costs
*Prepare regulatory strategies (including advising of the regulatory requirements) for new products and post-approval submissions with support from the Principal Registration Officer.
Experience Required:
*Degree in relevant science e.g: chemistry, pharmacy, biochemistry, biomedical sciences etc.
*12 months regulatory affairs experience (ideally within theEU)
*The ability to work under pressure, manage multiple projects and meet tight timelines.
*IT skills (Proficient in Microsoft Office, Adobe etc)
*Proficiency in speaking, comprehending, reading and writing English is required
Why this role?
Myclient are able to offer excellent career progression, and the chance to join a global health care company that is making a difference and changing lives. An excellent salary and benefits package is on offer with this role.
For further details about this role or other vacancies within Regulatory Affairs please contact Tim Barratt on +44(0)1727 817 626 or send a copy of your CVto 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.
Industry: Pharmaceuticals
Salary: £30000 - £35000 per annum
Salary Benefits:
Vacancy Type: Permanent
Job Skills: regulatory, regulatory officer, associate, executive, EU, post approval, registrations, MRP/DCP, regulatory affairs associate
Contact Name: Tim Barratt
Website: -
Direct Application URL: -