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Job Opportunity Details
Reference: QS0210
Title: Pharmaceuticals Senior Regulatory Affairs Executive
Location: Croydon
Job Type: Permanent
Salary: £30,000 - £40,000
Contact Person: Rashida Khan 0113 225 1547 apply@qualitystart.co.uk
Description: Your role as a Pharmaceuticals Senior Regulatory Affairs Executive based in Croydon will involve:
- Ensure timely submission of applications and negotiate favourable approvals.
- Provide regulatory and technical advice and support: actively participate in project team meetings.
- Ensure that the Company's activities comply with the appropriate regulatory guidelines and standards.
- 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.
- Regulatory documentation to ensure that a reliable, accurate and easily retrievable system is maintained.
- 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 Senior Regulatory Affairs Executive role you will have the following skills:
- A minimum of 3 years regulatory experience with a strong technical background.
- Bachelor's degree in Pharmacy or Life Science.
- Knowledge and experience of dealing with CMC data.
- Knowledge of MS Word, Excel, Adobe Acrobat, power point 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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