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Senior Regulatory Affairs Manager
1 week ago
You will be a part of an R&D-oriented international pharmaceutical company well known as a Global Speciality Pharma.
With a continuous flow of exciting projects in the pipeline your new company has placed emphasis on creating innovative medicines that meetinternational requirements.
Therapeutic areas include but are not limited to oncology, immunology and neurology.Key Responsibilities:
- Check for any new updates in legislation and regulatory guidance relevant to the work conducted
- Provide appropriate oversight of outsourced Service Providers making CTA submissions.
- Make sure filing of clinical trials documentation is kept up-to-date and compliant.
- All activities to be carried out in accordance with appropriate ICH GCP, UK, EU and other non EU legislation and guidance.
- Review/audit CRO reporting/procedures as and when appropriate
- Follow local SOPs and working guidelines.
- Assist the HRA to review and develop Regulatory Affairs SOPs and working guidelines.
- Assist HRA to guarantee appropriate training of staff (both internal and external) is provided.
- Maintain up to date knowledge and skills to ensure compliance with local requirements/legislation and GCP.
- Contribute to development and maintenance of company policies, SOPs and OPUK documents.
What You Need:
- BSc (or equivalent) in life sciences
- Experience with the EU CTIS system and UK combined ways of working
- Experience with eTMF
- Experience of late phase development and MAA submissions in EU/UK
What You Get:
- Competitive Salary
- Attractive Package (Bonus and Benefits)
If this job isn't quite right for you but you are looking for a new position, please contact Raiyan Jawad for a confidential discussion on your career.
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