Regulatory Affairs CMC (US Market)

Aurobindo Pharma

6 - 10 years

6 - 14 Lacs

hyderabad

Posted:16 hours ago| Platform:

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Skills Required

query handling post approval submissions usfda anda cmc osd cbe 30 pas module 2 module 3 reviewer regulatory affairs cbe 0 variation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers.
Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, quality, and regulatory standards in response.
Evaluation and good interpretation of post approval changes. Submission of supplements like CBE, CBE-30 and Prior Approval Supplement (PAS).Draft high-quality responses to regulatory agency letters (IR, DRL, CR) within stipulated timelines.
Evaluate and interpret post-approval changes & Review of Pharmaceutical Development Reports,
Review key regulatory documents such as specifications, process validation reports, hold time reports, stability protocols/data, Nitrosamine risk assessment reports, and technical packages.
Formulate US regulatory filing strategy for new projects.
Preparing quarterly and monthly targets. Allotting and evaluating targets of the team.

Good interpretation skill for ICH and FDA guidelines

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