Position: Senior Executive – Regulatory Affairs
Location: Tandalja – R&D, Gujarat
Company: Sun Pharmaceutical Industries Ltd.
Sun Pharmaceutical Industries Ltd., one of the leading global pharmaceutical companies, is looking for a talented and experienced professional to join their Regulatory Affairs team. This is a full-time position at their R&D facility in Tandalja, Gujarat.
Key Responsibilities:
- Review and Preparation:
- Review all data and documents related to product registrations for submission to various health authorities.
- Compile comprehensive registration dossiers for health authorities including the US, Canada, Europe, Australia, and China.
- Response Management:
- Prepare and submit responses to deficiency letters received from various regulatory agencies.
- Post-Approval Compliance:
- Maintain life-cycle management and post-approval changes for drug product registration dossiers.
- Cross-Functional Support:
- Provide regulatory support and guidance to cross-functional departments.
- Scientific Advice:
- Prepare and submit scientific advice requests to various health authorities.
- Electronic Submission:
- Compile, verify, and submit electronic dossiers using eCTD through the electronic gateway.
Preferred Expertise:
- Experience in handling regulatory requirements for Non-Oral dosage forms is preferable.
Qualifications & Skills:
- Proven experience in regulatory affairs, particularly in compiling and managing international registration dossiers.
- Familiarity with eCTD systems and electronic submissions.
- Strong understanding of life-cycle management for drug product registration.
- Excellent communication skills and ability to liaise effectively with health authorities.
Why Join Sun Pharma?
Sun Pharma offers a dynamic work environment, opportunities for professional growth, and a chance to be a part of cutting-edge pharmaceutical innovation. As a part of the Regulatory Affairs team, you will contribute to global healthcare solutions and ensure compliance with international regulatory standards.
Apply Now!
Be part of a company that values innovation, integrity, and excellence. Send your resume to Sun Pharmaceutical Industries Ltd. and take the next step in your career.
