You will be working in a team to support global regulatory activities for a portfolio of marketed products. This will involve preparing regulatory submission packages, liaison with product teams and the local operating companies and tracking submission status on a database. This will provide an excellent opportunity for an introduction to pharmaceutical regulatory affairs. You will gain experience of, and receive training on, regulatory requirements and guidelines, preparing regulatory submissions and pharmaceutical lifecycle management.
Responsibilities will include
- Populate and maintain a database of licence information
- Check and confirm information from a variety of sources:
- Product teams
- Local operating companies
- Client’s business partners
- Prepare core submission packages for Marketing authorisation variations and renewals
- Track regulatory status of submissions and prepare progress reports
- Attend and prepare minutes of project team meetings
What we are looking for
- Strong analytical skills: able to review and summarise scientific and administrative information, identify errors, inconsistencies and missing information
- Qualified to work in the UK
- Attention to detail: accuracy of work is essential to ensure correct details are registered and entered on to databases
- Teamwork: able to work effectively in a global team environment
- Project management: proven ability to manage assigned tasks, monitor progress and meet deadlines
- Communication skills: ability to clearly and confidently explain scientific and administrative issues both verbally and in writing
- IT skills: proficient use of standard office software (Microsoft Word, Excel and Outlook).
- Experience of working with databases would be an advantage..
- Life science or pharmacy degree
- Fluent in English
Accepted degree subjects
- biology and life sciences
- pharmacy and pharmacology
Additional job details
- Number of vacancies
- Letchworth Garden City
Bonus, pension, private medical insurance, life Insurance
- Contract, dates and working times
How to apply
Please send your CV and a message explaining why you want a career in regulatory affairs.
Click Apply to start your application now. This job will be available on Prospects until 25 August 2019
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Closing date: 6 September 2019