Senior Regulatory Officer

Senior Regulatory Officer - £40k circa

Location: Yorkshire - commutable from Doncaster, Huddersfield,York, Harrogate,Manchester, Bolton, Blackburn,Sheffield

Salary: £40,000 - Excellent package (negotiable)

- Discount with 1300 retailers
- Childcare vouchers
- Health care
- Pension scheme
- Discount gym membership
- Bonus and shares scheme
- Free car parking weekdays and weekends

Reporting to: Principal Regulatory Affairs Officer

Main Function:

* Problem Solving - uses legal requirements and knowledge to troubleshoot and actively seek ways to prevent issues arising.
* Runs meetings for licence projects
* Delivers training and presentations from courses. Trains junior staff
* To collate documents and prepare Marketing Authorisation Applications. To co-ordinate cross-functional teams to prepare responses to questions from authorities in a timely manner
* A senior officer must be able to demonstrate the following abilities:
* Planning and Organisation
* Prioritise own project workload and meet deadlines.
* Communication
* Customer Service to Internal Staff and external sources
* Inputs constructive ideas into decision making processes
* Attention to detail and provision of documentation in line with guidance
* Prepares packaging (specials and licensed), reviewing against excipient guideline, pack check, Braille check and conversant with EU braille. Submission to external databases, liaison with user test team. Translations. Knowledge of blue box information. Provides guidance to 3rd parties. Final sign off.
* Clinical Trial Applications collation, submission and responses. Review of junior staff dossiers. Good knowledge of biostudies and review of reports.
* Preparation of Type basic national variations. Preparation of Type II MR variations. Assessment of PSUR data. Review of junior staff variations.
* Licence preparation - National, Decentralised Procedure, Mutual Recognition, US and 3rd parties. Liaises with 3rd parties. Audits licences

If you are keen to find out more information contact or call Natalie Hopkins on 02077587311

To find out more about Real Staffing please visit www.realstaffing.com