Home
Jobs
Cadila Pharmaceuticals Limited logo

Regulatory Affairs Manager- ANDA (Injectable/Solid Oral)

0 years

0 Lacs

Ahmedabad Gujarat India

Posted:15 hours ago| Platform: Linkedin logo

Apply

Skills Required

reports controls maintenance database tracking training

Work Mode

On-site

Job Type

Full Time

Job Description


  • Handling of review and finalization of documents for Bioequivalence Sections (Module 5) & PADER.
  • Handling of regulatory queries/deficiencies for Bioequivalence Sections (Module 5).
  • Compilation, review and submission of registration dossiers in the regions of US.
  • Handling of regulatory queries/deficiencies.
  • Submission of Supplements Post approval activities: Annual Reports, post-approval supplements (CBE-0, CBE-30, PAS, RLD update, Safety Labelling change).
  • Review of documents for Bioequivalence such as Module 2.7 and Module 5 etc.
  • Review and approval of Change Controls & Deviations.
  • Creation and Maintenance of Regulatory Database for all the submissions.
  • Tracking of Regulatory Guidance Documents at the respective websites.
  • Imparting training across the team on new guidance documents.


Location:

More Jobs at Cadila Pharmaceuticals Limited

Assistant General Manager

Samba, Jammu & Kashmir, India

Experience: Not specified

|

Salary: Not disclosed

Assistant General Manager- Internal Audit

Samba, Jammu & Kashmir, India

10.0 - 10.0 yrs
|

Salary: Not disclosed

Manager Production Scheduling

Dholka, Gujarat, India

11.0 - 11.0 yrs
|

Salary: Not disclosed

Sales Manager

Mumbai

11.0 - 16.0 yrs
|

INR 25 - 30 Lacs

Sales Manager

Kochi

11.0 - 16.0 yrs
|

INR 25 - 30 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Reports 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.

Google Play App Store
coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now
Cadila Pharmaceuticals Limited
Cadila Pharmaceuticals Limited

Pharmaceuticals

Ahmedabad

Over 15,000 Employees

30 Jobs

    Key People

  • Sharvil Patel

    Managing Director

  • Pankaj R. Patel

    Chairman

RecommendedJobs for You

Cadila Pharmaceuticals Limited logo

Regulatory Affairs Manager- ANDA (Injectable/Solid Oral)

Cadila Pharmaceuticals Limited

Ahmedabad, Gujarat, India

Cadila Pharmaceuticals Limited logo

Regulatory Affairs Manager- ANDA (Injectable/Solid Oral)

Cadila Pharmaceuticals Limited

Ahmedabad, Gujarat, India