Regulatory Affairs -Europe

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 :

Dosage Form :

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