Regulatory Affairs Officer

2 weeks ago


Makarba Ahmedabad Gujarat, India Albios Lifesciences Pvt Ltd Full time

Designation - Regulatory Officer

Gender - Male/Female

Experience - 2 to 5 Years

Location - Makarba, Off S G Highway, Ahmedabad

Salary - Depend on experience

Working Days - 6 Days

Job Timing - 09:00 AM to 05:30 PM

Job Description - Preparation of CTD and ACTD Dossiers.
- Should have knowledge about Southeast Asian guidelines for Dossier preparation.
- Preparation and Reviewing Artwork
- Coordination with manufacturers regarding quality documents.
- Reviewing quality documents
- Should have sound knowledge of FDA related work. (Product Permission, COPP, Mfg. License, GMP certificate).
- Prepare and submit query response within timeline.

Skills - Good computer skills (MS Office), Proficiency in English, Excellent verbal and written communication skills

Pay: ₹25,000.00 - ₹30,000.00 per month

**Experience**:

- total work: 1 year (preferred)

Work Location: In person



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