Description
Regulatory Affairs ManagerSalary: £50,000 + Package
Location: London
If you have the leadership skills that are required for a global biotech company and can attribute and impact the company on a global scale this opportunity may be something you are looking for.
Description for the role you are applying for:
- Deliver professional regulatory advice and add to regulatory project work
- Ensure precise compilation, management and tracing of submissions
- Share in business development activities preparing regulatory sections of proposals and feasibility reports, regulatory costing and budgets and attend bid defence meetings
- Develop department work practices and other company ingenuities
- Close relationship with Managing Director
- Coordinate & manage regulatory & ethics committee submissions and maintain approvals throughout EMEA, Asia Pacific and Latin America regions
- Regulatory Affairs date intelligence
- Contribute towards the preparation of technical documentation such as IMPDs and IBs which may involve chemical, pharmaceutical, toxicological, pharmacological and clinical aspects of specified regulatory submissions
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc…to ensure compliance with ICH GCP & country specific requirements
- Liaise with CRAs
- Comply with SOPs, ICH GCP and national regulations as applicable
- Foster professional working relationships with internal and external contacts at the local and international levels to ensure expeditious submission/approval of regulatory dossiers
- Provide training, coaching and mentoring to junior members of staff, may be required to line manage junior members of staff
Requirements:
- Bachelor's Degree in Chemistry or Life Sciences, Nursing or equivalent experience
- Previous experience within the pharmaceutical/CRO industry
Good people usually know good people therefore referring a friend may also resolve in £250 referral vouchers.
To discuss further please call me on alternatively email me on L.khan at realstaffing.com