If you are looking to build a strong career in Regulatory Affairs, this opportunity at Sun Pharma could be your next big step. The company is known for its strong R&D capabilities and global presence, offering professionals a chance to work on impactful pharmaceutical projects.
Sun Pharma is hiring for the position of Executive โ Regulatory Affairs (India) at its Baroda location. This role is ideal for candidates with a solid background in regulatory documentation, dossier preparation, and submission processes.
Job Overview
Job Title
Executive Regulatory Affairs โ India
Department
R&D1 Regulatory Affairs
Location
Baroda (Vadodara), Gujarat
Experience Required
3 Years
Qualification
M.Pharm
Job Responsibilities
As an Executive in Regulatory Affairs, you will be responsible for handling end-to-end regulatory activities related to drug approval and compliance in India.
Key Responsibilities:
- Evaluation of regulatory strategies for product registration in India
- Review of CMC and regulatory documents
- Coordination with cross-functional teams for documentation corrections
- Preparation of application cover letters and regulatory submissions
- Compilation and submission of dossiers to CDSCO (HQ and Zonal offices)
- Handling approvals related to:
- Clinical Trials (CT)
- Bioequivalence (BE)
- Manufacturing and marketing permissions
- Managing import and marketing approvals in India
- Preparation and submission of IPC testing dossiers
- Handling post-approval changes and Phase IV CT applications
- Managing additional site approvals and notifications
- Handling BE permissions for export registration
- Processing permissions for drug testing and analysis (CT-10, CT-12, CT-13, Form 11, CT-17, Form 8)
- Reviewing product labeling artworks and coordinating corrections
Required Qualifications & Skills
Educational Qualification
- M.Pharm (Master of Pharmacy)
Experience
- Minimum 3 years of relevant experience in Regulatory Affairs
Skills Required
- Strong understanding of CDSCO regulatory requirements
- Experience in dossier compilation and submission
- Attention to detail and documentation accuracy
- Good communication and coordination skills
Salary and Benefits
Salary
- Estimated Salary Range: โน4,00,000 โ โน7,50,000 per annum (based on experience and skills)
Benefits
- Opportunity to work with one of Indiaโs leading pharmaceutical companies
- Exposure to regulatory processes and global standards
- Career growth and learning opportunities
- Supportive and collaborative work environment