Regulatory Affairs

2 weeks ago


Mumbai, Maharashtra, India Encube Ethicals Full time
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 (e CTD)
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 Bf Ar M
Thorough knowledge of EU Variations in EU
Knowledge of the review of CMC/Clinical/Regulatory documentation required for submission
Working capabilitles preferably on Pharma Ready or equivalent software
Working capabilities on CESP Portal preferred
Positive Attitude and Approach.
Learning Abilities

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