Regulatory Affairs Executive (Vadodara)

Regulatory Affairs Executive (Vadodara)

17 Sep
|
Ami Lifesciences
|
Vadodara

17 Sep

Ami Lifesciences

Vadodara

Roles and Responsibilities :

- Prepare and submit dossiers (CTD) for bulk drug products to European regulatory authorities.

- Ensure compliance with DMF requirements for API manufacturing facilities.

- Coordinate with cross-functional teams to ensure timely submission of regulatory documents.

- Maintain accurate records of all regulatory submissions and correspondence.

Job Requirements :

- 4-10 years of experience in Regulatory Affairs in the pharmaceutical industry.

- Solid knowledge of CTD format for dossier preparation.

- Experience working on bulk drugs regulations in Europe (DMF).

- Familiarity with API manufacturing processes.

📌 Regulatory Affairs Executive (Vadodara)
🏢 Ami Lifesciences
📍 Vadodara

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