JOB RESPONSBILITES
Expertise in ROW market, understanding nuances in regulatory demands across regions in-depth knowledge of FDA
Guidelines to ensure compliance in documentation and submissions.
Proficiency in handling technical documents to facilitate accurate and timely submissions
Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance
Strong analytical skills to assess regulatory data and provide critical insights for decision-making
Experience in dossier preparation, organizing comprehensive documents for regulatory authorities
Attention to detail to meticulously handle documentation and regulatory records
Excellent communication skills to liaise with regulatory agencies and internal departments
Preparation of registration dossiers as pe regulatory guidelines
Preparation of renewal application as per renewal guidelines
Facilitate query response raised by regulatory authority and customers
Preparation and submission of Safety, Quality & administrative variations as per variation guidelines
Must have Experience in Pharmaceutical - Formulation Plant
Pay: ₹20,000.00 - ₹30,000.00 per month
Benefits:
- Health insurance
- Leave encashment
- Paid time off
- Provident Fund
Work Location: In person
