6 - 9 years

7 - 8 Lacs

Posted:5 hours ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market.
  • Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market.
  • Draft controlled correspondences on complex issues.
  • Draft Deficiency responses for Complex Products and 505(b)(2) Products.
  • Review API and FP in-vitro characterization/sameness reports.
  • DMF review for complex APIs as per the workflow.
  • To collaborate and work closely with cross functional teams.

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
Amneal Pharmaceuticals logo
Amneal Pharmaceuticals

Pharmaceutical Manufacturing

Bridgewater New Jersey

RecommendedJobs for You

baramati, khamgaon, dhar