As Senior Regulatory Affairs Associate you will be responsible for obtaining licences for new products and maintaining licences for existing products as well as the compilation and submission of clinical trial applications.
- Obtaining and maintaining product licences by filing submissions to regulatory agencies.
- Provide answers to regulatory queries from the authorities.
- Provide regulatory input to and compiling clinical trial applications, end of trial notifications and other relevant documents.
- Using and updating corporate regulatory system database as required.
- Build strong relationships with junior and intermediate staff in the local regulatory agency.
- Provide excellent problem solving skills to complex issues.
- Develop, update and implement SOPs are required.
- Support Regional Regulatory Scientist for key assets.
- Life sciences degree.
- Experience within pharmaceutical regulatory affairs.
- Experience of compiling and submitting CTAs.
- Knowledge of licence renewals and variations.
- Excellent communication skills.
- Ability to prioritise workload.
For more information or to apply for this Senior Regulatory Affairs Associate position, please contact Meera Pattni on 01438 743 047 or email firstname.lastname@example.org.