Job Summary
Sun Pharmaceutical Industries Ltd is seeking a detail-oriented and motivated professional to join our R&D division in Baroda (Vadodara) as an Executive – Regulatory Affairs. This role is designed for candidates with 1–4 years of experience who are eager to advance their careers within a global pharmaceutical leader. The successful candidate will play a pivotal role in managing regulatory submissions, CMC documentation, and lifecycle management for MENA and other global markets. If you are passionate about regulatory strategy and looking to work in a high-impact, innovation-focused environment, this is an excellent opportunity to grow with a world-class team.
Job Overview
- Job Title: Executive – Regulatory Affairs
- Company: Sun Pharmaceutical Industries Ltd
- Location: Baroda (Vadodara), Gujarat
- Department: R&D Regulatory Affairs
- Experience: 1–4 Years
- Qualification: M.Pharm / M.Sc
- Employment Type: Full-Time
Responsibilities
Regulatory Submissions & CMC Documentation
- Prepare and review Chemistry, Manufacturing, and Controls (CMC) dossiers for new product submissions, renewals, and variations.
- Ensure all documentation adheres strictly to the regulatory requirements of MENA and other international markets.
- Review critical technical documents, including development reports, scale-up reports, stability protocols, specifications, and packaging artwork compliance.
- Oversee readiness for exhibit batch initiation to ensure seamless regulatory progression.
Deficiency Response & Lifecycle Management
- Draft and coordinate comprehensive responses to regulatory queries and deficiencies raised by health authorities.
- Collaborate with cross-functional teams to secure necessary internal approvals for regulatory filings.
- Manage product lifecycle activities, including updates related to API vendor changes, manufacturing site transfers, and test parameter adjustments.
- Prepare and file variations in alignment with country-specific guidelines.
Compliance & Data Management
- Maintain an organized central regulatory repository for all project documentation.
- Evaluate change controls to determine their regulatory impact on existing filings.
- Circulate detailed approval packages and historical product data to relevant stakeholders to ensure organizational alignment.
Requirements
- Educational Qualification: M.Pharm or M.Sc in Pharmaceutical Sciences or related Life Sciences fields.
- Professional Experience: 1–4 years of experience in a Regulatory Affairs role within the pharmaceutical industry, with a focus on CMC dossier preparation and global submissions (experience with MENA markets is highly preferred).
- Technical Skills:
- Proficiency in eCTD/CTD submission formats.
- In-depth knowledge of regulatory compliance and international submission guidelines.
- Strong ability to manage variation filings and technical documentation.
- Expertise in handling complex regulatory queries and deficiency responses.
- Soft Skills: Strong analytical thinking, excellent attention to detail, and the ability to work effectively in a collaborative, cross-functional environment.
Benefits
- Competitive Compensation: Salary range of ₹4 LPA – ₹8 LPA, commensurate with experience and expertise.
- Global Exposure: Gain valuable experience navigating the regulatory landscapes of major international markets, including MENA and South Africa.
- Professional Development: Work within a specialized R&D regulatory strategy environment that prioritizes continuous learning and career advancement.
- Company Culture: Join a “Create your own sunshine” culture that encourages innovation, collaboration, and personal growth within a leading global pharmaceutical organization.
How to Apply
If you meet the eligibility criteria and are interested in building your career with Sun Pharma, please visit our official careers portal to submit your application. You can view the full job description and apply directly through the link below:
Link: Apply for Executive – Regulatory Affairs at Sun Pharma
Sun Pharmaceutical Industries Ltd is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.