Home
Jobs

Regulatory Affairs-CMC- Queries

1 - 3 years

1 - 5 Lacs

Posted:1 week ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparation, review and compilation of assigned ANDA/NDA [505 b (2)]/projects for filing and knowledge of eCTD, Module 2 and 3. Hands on experience in reviewing CMC documents of Solid and Liquid Oral Dosage forms.

Preparation, review and compilation of Supplements and Amendments.

Review of Pharmaceutical Development Reports

Review of manufacturing documents like batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, hold time study reports, master formula cards, master packaging cards etc.

Review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols (multi point, multimedia and alcohol dose dumping etc), stability protocols and stability data

Mock Interview

Practice Video Interview with JobPe AI

Start Us Market Interview Now
cta

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Aurobindo Pharma
Aurobindo Pharma

Pharmaceuticals

Hyderabad

Over 18,000 Employees

31 Jobs

    Key People

  • N. Govindarajan

    Managing Director
  • K. Satish Reddy

    Chairman

RecommendedJobs for You