Asstt. Manager - Regulatory Affairs (US Market)/Formulations OSD Jubilant Pharmova

4.0 - 8.0 years

5 - 15 Lacs

greater noida

Hybrid

For US Market :- Drug Dossier Authoring, Reviewing & Submission of ANDA (US) Product life cycle management (LCM) activities Assessment of post approval changes eCTD publishing Thorough knowledge of CMC and Module 1 requirements Labelling submission, SPL preparation Preparation & Submission :- Authoring and review, compilation and submission of ANDA, DMF review and assessment, Query evaluation and response for under review ANDA within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation along with SPL preparation. Coordinat...

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Asstt. / Dy. Manager - Regulatory Affairs (US Market) Jubilant Pharmova

4.0 - 8.0 years

5 - 15 Lacs

greater noida

Hybrid

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Regulatory Affairs CMC (US Market) Aurobindo Pharma

6.0 - 10.0 years

6 - 14 Lacs

hyderabad

Work from Office

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 regul...

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