Job Opportunity in Regulatory Affairs – Cipla Hiring Team Member, FDA LL Unit

B.Sc/B.Pharm Job Opportunity in Regulatory Affairs – Cipla Hiring Team Member, FDA LL Unit – Delhi, 5-10 Years Experience

Explore Cipla’s opening in Delhi for B.Sc/B.Pharm graduates with 5–10 years of experience in Regulatory Affairs. Apply now for the Team Member – FDA LL Unit position.

Cipla Hiring B.Sc/B.Pharm Professionals in Delhi for Regulatory Affairs Role

Cipla Ltd., a pioneer in India’s pharmaceutical sector, is inviting applications for the position of Team Member – FDA LL Unit in Delhi. This role is ideal for professionals with 5–10 years of regulatory experience and an educational background in B.Sc or B.Pharm. If you’re looking to leverage your skills in a high-impact position with one of India’s most respected pharma companies, this could be the right fit.

Job Summary

Position: Team Member – FDA LL Unit
Company: Cipla Ltd.
Location: Delhi, India
Experience Required: 5–10 years
Education Required: B.Sc / B.Pharm
Department: Corporate Affairs – Regulatory
Job Posting Date: May 5, 2025

Key Responsibilities

Regulatory Submissions and Approvals

• Ensure timely approvals from State FDA and CDSCO for Cipla’s Loan License (LL) units.
• Prepare and submit applications for:
  • Fresh loan licenses
  • Test licenses
  • WHO-GMP, COPP, and other export-related permissions
  • India Business Tender Certificates
• Maintain the master tracker for FDA LL team permissions.

Cross-Functional Coordination

• Work with internal teams such as QA, R&D, and Regulatory Affairs to gather documents.
• Liaise with the FDA coordination team to ensure smooth application filing.

Stakeholder Engagement

• Build long-term relationships with key regulatory stakeholders: Deputy Drug Controller CDSCO, Drug Inspectors, and Assistant Drug Controllers.

Compliance and Monitoring

• Keep track of updates in pharmacopeial regulations and D&C Act rules.
• Oversee artwork approvals and check packaging labels against current regulatory norms.

Skills & Qualifications

Must-Have Qualifications

• Bachelor’s degree in Science (B.Sc) or Pharmacy (B.Pharm)

Required Skills

• Strong communication and coordination abilities
• Hands-on experience with FDA and CDSCO online portals
• Familiarity with India Business Tender requirements and labeling compliance

Experience

• 5 to 10 years of proven work experience in Regulatory Affairs within the pharmaceutical industry

Call to Action

If you meet the qualifications and are excited to work in a challenging regulatory environment, apply now on Cipla’s official career portal to take the next step in your pharmaceutical career.

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