Senior Regulatory Affairs Officer
5 days ago
You will be responsible for:
- Liaising with both internal and external stakeholders to ensure all regulatory requirements are met.
- Co-ordinating and submitting PSURs and preparing responses to questions from Regulatory Authorities.
- Monitoring product safety information, maintaining product labelling and reviewing artworks for use in submissions.
- At least 3 years experience in Regulatory roles within the Pharmaceutical industry.
- Strong knowledge of CTD requirements (modules 1 to 5).
- Experience working on EU MAA/Variation Submissions.
Regulatory Affairs | RA | Regulatory Affairs Officer | GMP | Pharmaceutical | Regulatory | Submission | Product Dossiers | EU | Global | MHRA | FDA | Good Manufacturing Practice | CTD | Common Technical Documentation | Module 1 | Module 2 | Module 3 | Module4 | Module 5 | eCTD
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