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Home
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Jobs in Ahmedabad
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Tashi Pharma
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Executive International Regulatory Affairs

Executive International Regulatory Affairs

1 - 2 years

|

4 - 8 Lacs

Posted:6 hours ago| Platform:

Apply

Skills Required

Market complaints Senior Executive GMP Regulatory affairs Technical documentation Auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparing, Reviewing and Submitting Product Dossiers as per Country Specific guidelines
Preparing, Reviewing and Submitting Renewal Dossiers / Variations.
Responding to queries raised by Regulatory authority of respective country.
Preparing CAPA reports for the audit or market complaints.
Coordinating with various department for Technical Documents as DMF, Stability data, FP COA, API COA, etc.
Coordinating & Arranging for the registration samples as per country guideline.
Reviewing & Approving the Artworks (Text Content)
Coordinating with FDCA Person for COPP & GMP and its legalization process.
Updating all registration status records.
Maintaining Retain Samples Records.
Coordinating with customer for filing of dossier & getting it timely approval.

SKILLS:

Fluent in English.
Good communication skills.
Ability to work under pressure and to meet deadlines.

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