Sun Pharmaceutical Industries Ltd, a global leader in pharmaceuticals, is hiring an Executive – Regulatory Affairs (RA) in Baroda (Tandalja – R&D). This role offers a unique opportunity to contribute to new drug submissions, regulatory approvals, and lifecycle management of drug products.
If you are an M.Pharm professional with 2–5 years of experience in regulatory affairs, this is your chance to thrive in a world-class research-driven environment.
Key Responsibilities
As an Executive – RA at Sun Pharma, your role will include:
- New Submissions:
- Collaborate with Product Development and cross-functional teams for regulatory input.
- Review, approve, and prepare high-quality dossiers to support faster approvals.
- Anticipate regulatory deficiencies and develop mitigation strategies.
- Support scientific discussions and agency interactions.
- Approvals:
- Prepare and submit timely responses to regulatory queries for faster product approval.
- Lifecycle Management:
- Handle annual reports, renewals, and post-approval variations.
- Ensure regulatory compliance and timely implementation of change management.
- Maintain a comprehensive central repository of product information.
- Self-Development:
- Stay updated on evolving regulatory guidelines.
- Participate in training, presentations, and regulatory knowledge-sharing.
Qualifications
- Education: M.Pharm (mandatory)
- Experience: 2–5 years in Regulatory Affairs (pharmaceutical industry)
- Location: Baroda, Gujarat (Tandalja – R&D)
- Travel Requirement: Not applicable
Why Join Sun Pharma?
At Sun Pharma, employees are encouraged to “Create Your Own Sunshine.” As part of the R&D Regulatory Affairs team, you will benefit from:
- A collaborative work culture with global exposure.
- Opportunities for continuous learning and skill enhancement.
- Career growth in regulatory strategy and submissions.
- Competitive salary and employee benefits.