Sun Pharmaceutical Industries Ltd. is one of the largest pharmaceutical companies globally, known for its high-quality, affordable medicines. With a strong presence in over 100 countries, Sun Pharma is a leader in specialty generics and innovative therapeutics. The company fosters a culture of excellence, innovation, and employee growth, making it a preferred workplace for professionals in the pharmaceutical industry.
Job Description: Regulatory Affairs Executive/Sr. Executive
Key Responsibilities:
- Regulatory Submissions:
- Prepare and review CMC (Chemistry, Manufacturing, and Controls) dossiers for new product submissions in the US and OAM (Other American Markets) regions.
- Ensure timely and accurate regulatory filings to facilitate product approvals.
- Product Approvals & Compliance:
- Review and respond to regulatory deficiencies to secure product approvals.
- Manage lifecycle activities, including variations, annual notifications, and labeling updates.
- Documentation & Compliance:
- Review development reports, scale-up reports, specifications, stability protocols, and analytical validation documents.
- Assess regulatory impact of change controls and file variations as per country-specific requirements.
- Regulatory Maintenance:
- Ensure eCTD (electronic Common Technical Document) compliance and compilation.
- Maintain updated product information in the central repository.
Skills & Qualifications:
- 4-9 years of experience in Regulatory Affairs (Formulations).
- Strong knowledge of US FDA, eCTD, and OAM regulatory guidelines.
- Experience in CMC dossier preparation, variations, and lifecycle management.
- Excellent documentation, communication, and analytical skills.
Why Join Sun Pharma?
✅ Industry Leader: Work with a globally recognized pharmaceutical giant.
✅ Career Growth: Opportunities for professional development and advancement.
✅ Hybrid Work Model: Flexible work arrangement (Office + Remote).
✅ Employee-Centric Culture: Positive work environment with a focus on employee well-being.
