Regulatory Affairs (US/EU - Formulations) - Senior Manager / Team Lead

10 - 15 years

20.0 - 25.0 Lacs P.A.

Hyderabad

Posted:2 months ago| Platform: Naukri logo

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Skills Required

Regulatory Affairsoral solidsEuropepre and post approvalNDAEurope MarketUS Marketparenteral dosage formsDossiersRACTDAndaFormulationEU Generic

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities Should handle a team of 4-10 members. Must have experience into formulations US - ANDA/NDA and EU Generic/Hybrid applications. Should be familiar with oral solids and parenteral dosage forms. Should familiar with pre and post approval regulatory activities. Should handle the customer and Agency queries. Should handle other regulatory activities based on organization need. Should support plant RA activities and other CFTs as needed. Desired Candidate Profile Perks and Benefits

Pharmaceutical Manufacturing
RAICHUR Karnataka

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