Regulatory Affairs Manager
Real Staffing have partnered with a global pharmaceutical company that is a market leader in their area of specialty.
Due to an increase in work demand, our client is currently in need of a Permanent Regulatory Affairs Manager to join their team.
The role will be reporting to the Director of Regulatory Affairs initially be based in the office.
Provide regulatory support for development projects to ensure submission of Competent Authority applications in line with project goals
Senior Regulatory Manager (South West) Job Description: Managing regulatory submissions and the maintenance of regulatory documentation. Ensuring regulatory compliance. Responsibilities:
- Preparation of initial IND/CTA submissions and maintenance through to study completion, including oversight of external CROs where appropriate
- Prepare and/or review clinical trial associated documentation.
- Provide support, where required, in the preparation for Regulatory Agency meetings (e.g. scientific advice).
- Support the preparation of other regulatory documentation.
- Provide input to regulatory strategies for development products
- Maintain current knowledge of relevant legislation in the UK, EU, US and all appropriate guidelines (including ICH).
- A degree or equivalent in a Life Science subject.
- 3-5 years of regulatory experience with a significant proportion managing Phase I-III clinical trials, ideally within a CRO or a small biotech company.
- Demonstrated ability to work with cross functional teams.
- Strong medical or technical writing skills and attention to detail.
Please use a cover letter to highlight how you meet the criteria for the role (highlighting your experience)Your cover letter along with your CV will be used to assess your application.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales