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Job Opportunity Details
Reference: QS0209
Title: Pharmaceuticals Regulatory Affairs Manager
Location: Croydon
Job Type: Permanent
Salary: £40,000 - £60,000
Contact Person: Rashida Khan 0113 225 1547 apply@qualitystart.co.uk
Description: Your role as a Pharmaceuticals Regulatory Affairs Manager based in Croydon will involve managing the regulatory affairs department ensuring timely submission of applications and negotiate favourable approvals. You will provide regulatory and technical advice and support: actively participate in project team meetings.
Other duties include:
- Ensure that the Company's activities comply with the appropriate regulatory guidelines and standards, pre-empting potential issues and suggesting possible solutions.
- Prepare and review CMC elements of regulatory documentation.
- Ensuring Regulatory Compliance and Good Regulatory Practice throughout the Regulatory Team and resolving regulatory problems arising to achieve a satisfactory outcome.
- Overall responsibility for regulatory documentation to ensure that a reliable, accurate and easily retrievable system is maintained.
- Ensuring that adequate regulatory systems and procedures are in place and are adhered to.
- Regular training of staff on SOPs and company procedures.
- Ensuring that regulatory documentation is safely stored, up to date and easily and completely retrievable in accordance with current standards.
Skills: In order to apply for the Pharmaceuticals Regulatory Affairs Manager role you will have the following:
- A minimum of 5 years regulatory experience with a strong technical and management background.
- Bachelor's degree in Pharmacy or Life Science.
- Knowledge and experience of dealing with CMC data.
- Knowledge of MS Word, Excel, Adobe Acrobat, Powerpoint and web surfing and regulatory document management systems e.g. Documentum.
- Knowledge of European Regulations, guidelines and application procedures.
How to Apply: In order to apply for this vacancy please email your CV to apply@qualitystart.co.uk quoting the reference number and the job title.
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