Are you a Regulatory Affairs professional looking for an exciting opportunity in the pharmaceutical industry? Jubilant Biosys, a leading global pharmaceutical company, is hiring Regulatory Affairs Executives specializing in Emerging Markets. This is your chance to join a dynamic team and contribute to the development and approval of life-changing medicines.
📌 Job Details
- Position: Executive – Regulatory Affairs (Emerging Markets)
- Company: Jubilant Biosys Limited (Part of Jubilant Pharma)
- Location: Greater Noida, Uttar Pradesh, India
- Job Type: Full-time
- Experience: Relevant experience in regulatory affairs preferred
- Salary: Competitive, based on experience
🏆 About Jubilant Biosys
Jubilant Biosys is a globally recognized pharmaceutical company known for its innovation in drug discovery, development, and regulatory compliance. As part of Jubilant Pharmova Limited, the company operates across multiple geographies, providing high-quality pharmaceutical products and services.
With a strong focus on Emerging Markets, Jubilant Biosys plays a crucial role in ensuring regulatory compliance, dossier submissions, and product lifecycle management.
📋 Job Description & Responsibilities
Key Responsibilities:
✔ Regulatory Dossier Management – Authoring, reviewing, and submitting drug dossiers for Emerging Markets (Middle East, Africa, etc.)
✔ Product Lifecycle Management (LCM) – Handling post-approval changes, variations, and renewals
✔ CMC & Module 1 Expertise – Ensuring compliance with Chemistry, Manufacturing, and Controls (CMC) requirements
✔ eCTD Publishing – Preparing and submitting electronic Common Technical Documents (eCTD)
✔ Regulatory Intelligence – Staying updated with global regulatory guidelines and trends
✔ Cross-functional Coordination – Working with R&D, API vendors, and business teams to resolve technical queries
Challenges You’ll Tackle:
- Navigating complex regulatory requirements in Emerging Markets
- Managing labeling compliance and regulatory impacts
- Ensuring smooth dossier submissions and approvals
✅ Desired Skills & Qualifications
- Educational Background: Bachelor’s/Master’s in Pharmacy, Chemistry, or Life Sciences
- Experience: Prior experience in Regulatory Affairs (Emerging Markets preferred)
- Technical Skills:
- Strong knowledge of CMC, Module 1, and eCTD submissions
- Familiarity with Middle East & Africa regulatory guidelines
- Soft Skills: Excellent communication, attention to detail, and project management
🚀 Why Join Jubilant Biosys?
- Work with a globally recognized pharmaceutical leader
- Opportunities for career growth & skill development
- Be part of a dynamic regulatory team handling diverse markets
- Competitive salary & benefits
