Required Regulatory Affairs Officer/Sr.Officer- (ROW Market)

Exemed

2 - 5 years

2 - 4 Lacs

vadodara

Posted:6 days ago| Platform:

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Skills Required

dossier drug regulatory affairs ctd dossier preparation formulation cgmp row actd ectd ich

Work Mode

Work from Office

Job Type

Full Time

Job Description

Company Name: Exemed Pharmaceuticals

Designation - IRA Officer/Sr.Officer

Location - Vadodara ( Corporate Office)

Role & responsibilities

Prepare, review, compile and submit regulatory dossiers (CTD/ACTD/Country specific format).
Communicate with cross functional team for CMC documents, review and provide feedback to team.
Keep up-to-date with changing global regulations.
Communicate regulatory updates to internal teams.
Maintain updated regulatory files and technical documents till Product life cycle management.
Respond to regulator queries received from Internal and External stake holders within timeframe.
Review of artworks as per labelling requirement of various countries for regulatory compliance.
Communicate with cross functional team and internal team to arrange and submit samples of products as per country requirement.
Ensure timely renewal of regulatory licenses and approvals.
Knowledge of Liasoning activities i.e. Test licence, PP and CoPP applications.

If interested share your updated resume on recruitment@exemedpharma.com

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