Compliance Expert
5 days ago
Aspire Pharma Limited seeks a highly skilled Regulatory Affairs Specialist to join our team.
This role requires strong regulatory knowledge and compliance expertise to ensure the smooth maintenance and submission of regulatory information and documentation.
The successful candidate will be responsible for compiling, publishing, and submitting new product dossiers and technical files in the UK, EU, and RoW as required by the business.
Key Responsibilities:- Ensuring regulatory compliance and submission of regulatory information and documentation for medicines, medical devices, and other products.
- Coordinating with internal and external stakeholders to prepare responses to requests for information from regulatory authorities within stated timelines.
- Assisting with regulatory due diligence of new products using knowledge of current regulations and guidance.
- Proactively liaising with internal and external stakeholders regarding issues relating to projects.
- Maintaining awareness of new and existing legislation and guidance from regulatory competent authorities.
- Degree in a scientific or similar discipline.
- Proficient in Microsoft Office packages such as Word, Outlook, PowerPoint, Excel, and also having the ability to learn other in-house programs (SharePoint).
- Scientific writing.
We offer a competitive salary and company benefits package including:
- Generous Pension Scheme.
- Life Assurance cover and Employee Assistant Program.
- 25 days' holiday plus Bank Holidays.
- Learning and Development opportunities.
- Fantastic Company events and celebrations throughout the year.
Salary: £45,000 per annum.
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