Description
Regulatory Affairs Officer - Global Pharma - £23,000 to £27,000 + Competitive Benefits - Regulatory Affairs Team - Full Lifecycle Experience - Southeast EnglandThis Global Pharma is looking for an individual to join their Regulatory Team. This role is the perfect opportunity to truly develop your industry experience as you will also be involved with Pharmacovigilance and Quality Assurance. This role will provide opportunity for career development and advancement for the correct individual.
Main Responsibilities:
- Preparing and submission of minor dossiers for Type IA and IB variations
- Reviewing of Annual Product Quality Review Data for all products and writing summary reports.
- To assemble the information required for the resolution of regulatory issues. To answer most uncomplicated regulatory queries, but refer complex issues upwards. May have delegated responsibility for minor projects/products.
- To participate in the establishment and maintenance of effective procedures for regulatory compliance.
- To evaluate proposed changes to specifications, manufacturing processes, test methods etc., to determine compliance needs and to advise on data generation required, with consultation with their supervisor as needed.
- Liaising with PV with regards to Anonymised single patient reports
The correct individual will have:
- Life Science degree
- 6 months-1 years experience in regulatory affairs/pharmacovigilance within the UK pharmaceutical industry.
- Good administrative skills and proficient knowledge of word and excel.
- Be eligible to work in the UK
Real Pharma are a world leader in placing regulatory affairs professional, with nearly 10 years experience in this market we are specialists who make sure we place the correct candidate in the correct environment.
For more information on this opportunity please contact Ben Moseley on or send you CV to b.moseley(a)realstaffing.com Sthree UK is acting as an Employment Agency in relation to this vacancy.