Regulatory Affairs

3 days ago


Maharashtra India Govandi USV Full time

ear Candidate,

We are seeking a Senior Executive/ Assistant - Regulatory affairs Europe)  to join our team, He/ she will be responsible for Dossier compilation, preparation, Life cycle management, Pre approval, Post approvals. based at Govandi Location.

Markets : Europe

Dosage Form :  OSD/ Sterile

Key Responsibilities:

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

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

● Collate and conduct first-level review/overview of relevant standard technical documentation like stability, TTD, PDR, method validations etc. as per the country requirements.

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

● Conduct initial 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 Europe

Proficiencies and Expertise

● M. Pharma

● Proven experience in Regulatory affairs with 6-12 year of handling OSD/ Sterile Dosage form for Europe  market would be preferred



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