Senior Officer

4 days ago

Navi Mumbai, Maharashtra, India USV Full time ₹ 5,00,000 - ₹ 15,00,000 per year

Job Description

Position Summary

We are seeking a Senior Officer- Regulatory affairs (US Markets ) to join our team, he will be reporting to Deputy General Manager in this role, you will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approval

Key Responsibilities:

Collate/prepare and file dossiers in a timely and accurate manner for formulations/ drug products to get licenses from targeted markets.

Prepare the checklist for documentation for regulatory filings as per current regulatory requirements (country specific).

Collate and conduct review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations, Extractable/leachable reports, filter validation, CCIT reports, Qualification/requalification summary, Comparative Drug Product Characterization etc. as per the country requirements.

Conduct review of the specifications of the API / Semi-Finished Product / Finished Product as per the regulatory requirements

Preparation and review of sterility assurance package (media fill summary, qualification summary, etc), DHF, Comparative Analyses and HF studies reports for combination products as per the regulatory requirements.

Conduct review of labelling /artwork as per the market where the dossier is being filed

Review and regulatory impact analysis of the change control, communication with customer for notification and approval as applicable.

Review and regulatory impact analysis of the changes notified by the vendors as per current regulatory requirements (country specific), as desired.

Evaluate any changes proposed post-approval. Prepare and file necessary amendments / supplements / annual reports as applicable to ensure regulatory compliance (Post-approval Life Cycle Management).

e-CTD compilation/ publishing of DMF / Dossiers and Submission to customer / Health Authorities.

Assist in resolution of queries received from customer/agency/regulator and assessing them before sharing with team leader.

Preparation of Approval Package and sharing them with the respective manufacturing sites.

Prepare and e-file documents for registration of any facility used (in process for drug) with USFDA.

Proficiencies and Expertise

Master's degree/ Bachelor degree in Pharmaceutics 

Proven experience in Regulatory affairs with 2+ years of experience.

Should have worked in USA markets

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