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Biophore
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Executive - RA (API)

Executive - RA (API)

2 - 5 years

|

3 - 5 Lacs

Posted:10 hours ago| Platform:

Apply

Skills Required

regulatory affairs dmf api manufacturing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Organizing, maintaining, and filing regulatory documents golbally, ensuring compliance with regulatory guidelines.
Prompt regulatory support to the customers.
Collaboration & engaging in periodic customer teleconferences to resolve queries
Change control evaluation and plant support
Scheduling the life cycle management activities globally for all the regulatory submissions complying with region specific requirements
Ensure the Drug Master File (DMF) deficiency letters received from various regulatory agencies globally are responded in time with adequacy and accuracy.

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