As Senior Regulatory Affairs Executive, you will be required to apply for and maintain product licences held by the company.
Your main responsibilities will include:
- You will be responsible for the life cycle management of all company products through the preparation and submission of application, renewals and variations to the regulatory authorities.
- Prepare responses to questions from the regulatory authorities.
- Follow up with regulatory authorities to determine the status of submissions.
- Request, review and submit PSURs.
- Write, review and advise on SmPCs and packaging.
- Keep up to date with any changes in legislation and communicate these to colleagues.
- You will be responsible for the day to day supervision of the Regulatory Administrator.
The ideal candidate for this Senior Regulatory Affairs Executive position will have the following skills and experience:
- Ability to prioritise workload.
- Work as part of a team as required.
- Previous experience working in pharmaceutical regulatory affairs.
- Life sciences degree.
- Knowledge of the drug development process.
For more information or to apply for this Senior Regulatory Affairs Executive position, please contact Meera Pattni on 01438 743 047 or email firstname.lastname@example.org. Entitlement to work in the EEA is essential. Please quote reference CL21147 in all correspondence.