Sun Pharmaceutical Industries Hiring For Regulatory Affairs

Sun Pharmaceutical Industries Ltd. is inviting applications for a position in Regulatory Affairs – Labeling (US Market) at its Vadodara location. The role involves managing and supporting US market labeling activities, including ANDA dossier labeling, artwork review, regulatory labeling updates, and post-approval maintenance in compliance with US FDA requirements.

Job Details

Position

Regulatory Affairs – Labeling (US Market)

Job Responsibilities

Selected candidates will be responsible for:

1. Reviewing and completing labeling activities for ANDA dossiers for regulatory submissions.
2. Preparing and reviewing responses to labeling deficiencies to support regulatory approval.
3. Preparing and reviewing artwork changes for:
   • Cartons
   • Labels
   • Package inserts
   • Medication guides
   • Instructions for Use (IFUs)
   • Other packaging components
4. Reviewing and implementing labeling changes based on FDA approval letters, SPL updates, labeling supplements, safety-related changes, customer-specific requirements, and innovator labeling updates.
5. Coordinating with cross-functional teams to support labeling activities.
6. Reviewing artwork files to ensure compliance with approved labeling text and regulatory requirements.
7. Supporting ANDA post-approval labeling maintenance activities.
8. Supporting the implementation of labeling updates within established timelines.
9. Maintaining labeling documentation and ensuring proper archival of approved records.
10. Ensuring compliance with internal SOPs, regulatory requirements, and Good Documentation Practices (GDP).

Eligibility and Qualifications

The job description focuses on experience and responsibilities related to US market regulatory labeling, ANDA dossiers, artwork review, and post-approval labeling maintenance.

How to Apply

Interested candidates can share their updated resumes through the following email address:

Email: Rosemary.varghese@sunpharma.com