Posted:4 hours ago|
Platform:
Work from Office
Full Time
Alembic Pharma is hiring: The regulatory affairs professional will be responsible for preparation and submission of ANDA, ensuring compliance with current regulatory requirements. Job profile: To execute regulatory plans aligned with business strategy for complex drug products Review of protocols, reports, batch documents, development data received from stakeholders and ensure compliance of documents. To perform gap analysis on regulatory documentation and propose solution and ensure required compliance. Manage documents, prepare and process compilation in eCTD Preparation of ANDA considering US FDA requirements. Preparation of amendments and supplements. Preparation and review of labeling artworks Review of DMF Review of extractable, leachable, elemental impurities and nitrosamine assessment, in-use and stability data. Liaise with external stakeholders Archiving of communications and maintenance of status files and database Requirements: Education: Pharma Graduate OR Post Graduate Experience: 02- 08 years Desirable traits: Ability to manage complex projects and timelines in a matrix team environment. Ability to work independently and as part of a team. Should have hands on experience on MS word, PDF professional, eCTD software for ANDA preparation and submission. Interested candidate can share cv on bdcv@alembic.co.in
Alembic Pharmaceuticals
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