Description
Regulatory Affairs ManagerLocation: West London commutable from London, Berkshire, Watford, some areas of Bucks
Salary: £60 - £65K + Benefits package
This is an excellent opportunity working for a successful growing organisation. They are looking for an experienced professional who has the ability to lead a team from the front. You will get exposure to the most senior management in the company allowing you to be involved in key strategic decisions.
RESPONSIBILITIES
- Oversee the regulatory affairs team in the UK (6-8) and a team of 4 aboard.
- Prepare and review submission packages to the MHRA and IMB in a timely manner
- Write and prepare responses to a high quality
- To raise and action appropriate change control, maintaining compliance
- To prepare and submit high quality submission for post approval activity to strict dead lines
- Liaise with the Regulatory Authorities to ensure product approvals are received in a timely manner
- Review artwork for national phase submission and prior to launch
- Review health authority website for product safety updates and new requirements
ESSENTIAL EXPERIENCE
- MSc or BSc Pharmaceutical Science,
- Previous experience 6-10 years
- Module 2 sign off ideal
- Must have high attention to detail and proactive
- Ability to prepare high quality regulatory applications and the ability to communicate effectively
- Ability to handle multiple tasks in a fast-paced and constantly changing environment
- Ideally some knowledge of drug development
- Ideally some knowledge of Decentralised procedures
If you are keen to find out more information please contract Natalie Hopkins (Senior Regulatory Consultant) on n.hopkins (a) realstaffing.com with your C.V or call for more details.