Description
Operations Regulatory Senior Associate / Operations Regulatory Specialist / Regulatory Submission Manager - £35,000 - £55,000 + Excellent package including paid overtime & Car allowance for the top levels - BerkshireA rapidly growing company is looking to hire a number of driven and committed individuals to join their team. This company offers excellent career progression for the correct individual looking to join a developing team in which to expand their experience and knowledge on an incomparable level working with this global company.
The package:
- £35,000 - £55,000 (varies depending on experience and level)
- Life Insurance
- Health Insurance
- Bonus Incentives
- Pension Scheme
- Car Allowance (dependant on seniority of position)
The Role:
- To support Regulatory Operations in the generation of electronic submission
- Conduct regulatory reviews of technical summaries, quality, non-clinical and clinical study reports
- Assist with the filings and approval processes for MAA products within all types of European Regulatory Procedures.
- Assist with the assembly of Common Technical Document (CTD) and electronic CTD filings
- Assist with providing regulatory expertise on of MA life cycle management (variations, renewals, labeling, and line extensions
What we're looking for
- Experience in the pharmaceutical industry
- Practical experience with electronic submissions, preferably eCTD
- Project management skills
- Ability to work in a geographically spread team environment
- Ability to work on numerous projects (multi-task)
- MS Office skills
- Knowledge of publishing software and tools
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
To find out more about Real please visit www.realstaffing.com