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

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

Shilpa Medicare

10 - 15 years

|

20 - 25 Lacs

Posted:4 days ago| Platform:

Apply

Skills Required

regulatory affairs oral solids europe pre and post approval nda europe market us market parenteral dosage forms dossiers ra ctd anda formulation eu 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

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Shilpa Medicare

Pharmaceutical Manufacturing

RAICHUR Karnataka

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