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Regulatory Affairs
1 month ago
Key Deliverables
- Dossier compilation of initial MAA for Europe Market
- Response to EU authorities deficiency
- Scientific Advice
- Variations and Supplements (Type IA, IA, Type IB Type
- Timely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
- Hands on Electronic Operation (eCTD)
- E Submission Gateway
- Behavioral Aspects
Skill Requirements
- Min 5 years experience in Europe submission via DCP/MRP or National
- Experience in addressing the EU authority deficiencies satisfactorily
- Understanding and knowledge about presentation of data in Scientific advise from EU Agencies such as BfArM
- Thorough knowledge of EU Variations in EU
- Knowledge of the review of CMC/Clinical/Regulatory documentation required for submission
- Working capabilitles preferably on PharmaReady or equivalent software
- Working capabilities on CESP Portal preferred
- Positive Attitude and Approach. Learning Abilities
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