Job Reference: 1507-3
Job Duration:
Start date: A.S.A.P
Description:
An excellent opportunity has arisen for a Senior Regulatory Officer to join a global team within a specialist Pharmaceutical company based on the South Coast. Within this role you will gain a large amount of exposure working closely with R&D, QA and PV teams. The ideal candidate will have a strong background in biologic or sterile products.Job Specific Responsibilities:
*Ensure regulatory systems, such as Regulatory Database /trackers are implemented and keptup to date.
*Work with internal & external customers to provide data and accurate regulatory input
*Prepare & reviewlabelling/Packaging text. Promotional reviews
*Communicate with regulatory agencies and document communication
*Prepare, Review and sign off change control risk assessments
*All paper and electronic files kept up to date and easily locatable
*Input into team activities e.g. brainstorming, best practices etc.
*Prepare & review assigned SOPs
*Prepare & review new product dossiers and annual updates
*Preparation & review of high quality timely submissions/responses and follow up of actions arising from Regulatory Authority commitments.
*Review and approval of CTA/IND submission and maintenance documentation
*Prepare & review new product dossiers and annual updates
Qualifications/Experience required:
*Relevant life sciences degree*A background in biologic or sterile products
*Minimum of 3-5 years in the pharmaceutical field
*Demonstrated ability to writegood quality documents
*Communication skills
*Attention to detail/accuracy
*Project management
*Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
*Proficient user of Microsoft Office
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 goodvalue 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, throughoutEurope 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, biologics, sterile, regulatory officer, senior officer, global, post approval, CTA, IMPD, specialist, emerging markets
Contact Name: Tim Barratt
Website: -
Direct Application URL: -