Home
Jobs

Executive/ S. Executive Regulatory Affairs

3 - 7 years

6 - 9 Lacs

Posted:2 weeks ago| Platform: Naukri logo

Apply

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Preparation and reviewing of CTD and ACTD dossier.

2. Co-ordination with Plant and R&D to collect inputs required for Regulatory Submission.

3. Co-ordination with plant for Regulatory compliances.

4. Timely achievement of monthly plan & timely query response.

5. Gap Analysis/Updation of Master data.

6. Get feedback from all the countries for respective variation, and their timely submission.

7. renewals.

8. Master data Updating.

9. Follow ups with plant for documentation regularly and review meeting.

Preferred candidate profile

  • eCTD, CTD, Validation, ICH requirements, USFDA Filings, WHO Prequalification, MCC South Africa for Biological and Biotech products
  • Must have exposure to in-licensed dossier filing and out licensing

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
Bharat Serums and Vaccines
Bharat Serums and Vaccines

Biopharmaceuticals

Mumbai

RecommendedJobs for You