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Regulatory Affairs-Sterile

Regulatory Affairs-Sterile

Onesource Specialty Pharma Limited

2 - 7 years

3 - 8 Lacs

Hyderabad Chennai Bengaluru

Posted:1 day ago| Platform:

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Skills Required

Regulatory Affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Assist in preparing and submitting regulatory documentation for sterile products (e.g., FDA 510(k), CE Technical Files, DMFs).
Support regulatory strategy development and maintain knowledge of global sterile product regulations.
Help manage product registrations, licenses, and renewals in various markets.
Collaborate with R&D, Quality, and Manufacturing teams to ensure regulatory compliance during product development and changes.
Track regulatory requirements, guidance updates, and assist in audit preparations.
Maintain organized regulatory files and documentation.

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