RA/RS- Regulatory Affairs

4 - 9 years

0 Lacs

Posted:2 days ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Reviewing submission related documents including Inactive Ingredient Evaluation, Q1/Q2, Product Development Report, Quality Plan, Product Manual, Trade dress, Specifications, Master Packaging Card and Validation Protocols/Reports etc.
  • DMF Review for ANDA submissions.
  • Outlining requirements for labelling, storage and packaging for FDA submission.
  • Compilation of ANDA sections of US market for sterile dosage form.
  • Review of manufacturing related documents such as BMR, BPR and Stability study Protocols /Reports etc.
  • To draft response and timely submission for regulatory deficiencies.
  • To coordinate with cross-functional teams for regulatory requirements.
  • Keeping up to date with regulatory guidelines

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview
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
Mankind Pharma logo
Mankind Pharma

Pharmaceuticals

Delhi

RecommendedJobs for You

Warangal, Hyderabad, Nizamabad