AM/DM - Regulatory Affairs (UK Market)

Jubilant Generics Limited India, Uttar Pradesh, Ghaziabad, Noida
Posted 2 months ago

Job Description

UK: - Drug Dossier Authoring, Reviewing & Submission of dossiers Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission Preparation & Submission: - Draft, critically review, and submit high‑quality regulatory dossiers (e.g., MAAs, variations, renewals) in eCTD format, ensuring alignment with EU (EMA/NCAs) and UK (MHRA) requirements, region‑specific templates, and submission porta…

Requirements

Employment Type

Permanent

Category

Scientific & QA Jobs

About Jubilant Generics Limited

Location: India, Uttar Pradesh, Ghaziabad, Noida

Industry: Scientific & QA Jobs

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