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Pharmaceutical,
Biopharma
ؠDossier compilation of Initial MAA for Europe Market
ؠResponse to EU authorities deficiency
ؠScientific Advice
ؠVariations and Supplements (Type IA, IA1n, Type 1B Type II
ؠTimely review of technical and regulatory documents i.e. Specifications, batch records, method validation documents, Stability data, container closure system, DMF review.
ؠHands on Electronic Operation (eCTD)
ؠE Submission Gateway
ؠBehavioural Aspects
M.Pharm (preferably in Regulatory/Chemistry/Pharmaceutics
ؠMin 5 years experience in Europe submission via DCP/MRP or National
ؠExperience in addressing the EU authority deficiencies satisfactorily
ؠUnderstanding and knowledge about presentation of data in Scientific advise from EU Agencies such as BfArM
ؠThorough knowledge of EU Variations in EU
ؠKnowledge of the review of CMC/Clinical/Regulatory documentation required for submission
ؠWorking capabilities preferably on Pharma Ready or equivalent software
ؠWorking capabilities on CESP Portal preferred
ؠPositive Attitude and Approach. Learning Abilities
Role:Regulatory Affairs Executive, Regulatory Affairs Manager
Industry:Pharmaceutical, Biopharma
Function:Pharmaceutical/Biotechnology
Job Type:Permanent Job
Date Posted: 26/11/2024
Job ID: 101509339
Nova HRO comprises of professionals who have been in the business for over a decade and have a combined experience of over 100 man years of experience in the industry. The team comprises of professionally qualified people – in business management, marketing, education, finance, consulting and experience across industry sectors.
