Deputy Regulatory Affairs Manager

5 days ago


Ahmedabad, Gujarat, India Opes Healthcare Full time ₹ 4,00,000 - ₹ 12,00,000 per year

Role & responsibilities

To lead Regulatory affairs team engaged in dossier preparation in CTD and ACTD formats.

Responsible for final review of dossier before submission.

Reviewing artwork for products as per relevant regulatory authority requirements.

Coordination with F&D, QA, QC & Store for documentation

In-depth knowledge of pharmaceutical documentation & regulatory guidelines.

To coordinate with technical team for documents required for dossier.

Country Experience Preferred: CIS, LATAM

Dosage Form Experience: Soild Oral + Injectable

Preferred candidate profile


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