AM/DM - Regulatory Affairs (UK Market)
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