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

Jubilant Pharmova

4 - 8 years

5 - 15 Lacs

greater noida

Posted:1 day ago| Platform:

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Skills Required

cbe 30 anda cmc us market module 3

Work Mode

Hybrid

Job Type

Full Time

Job Description

For

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.
Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities
Review and finalization of artwork/label as per current guideline.
Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends
eCTD publishing

Coordination :-

Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner
Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements
To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D/ADL against DMF/Dossier requirements

Reporting & Maintenance :-

Maintain regulatory files/database

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