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.
๐ Job Details
- Position:ย Executive โ Regulatory Affairs (Emerging Markets)
- Company:ย Jubilant Biosys Limited (Part of Jubilant Pharma)
- Location:ย Greater Noida, Uttar Pradesh, India
- Job Type:ย Full-time
- Experience:ย Relevant experience in regulatory affairs preferred
- Salary:ย Competitive, based on experience
๐ 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.
๐ Job Description & Responsibilities
Key Responsibilities:
โ Regulatory Dossier Management โ Authoring, reviewing, and submitting drug dossiers for Emerging Markets (Middle East, Africa, etc.)
โ Product Lifecycle Management (LCM) โ Handling post-approval changes, variations, and renewals
โ CMC & Module 1 Expertise โ Ensuring compliance with Chemistry, Manufacturing, and Controls (CMC) requirements
โ eCTD Publishing โ Preparing and submitting electronic Common Technical Documents (eCTD)
โ Regulatory Intelligence โ Staying updated with global regulatory guidelines and trends
โ Cross-functional Coordination โ Working with R&D, API vendors, and business teams to resolve technical queries
Challenges Youโll Tackle:
- Navigating complexย regulatory requirementsย in Emerging Markets
- Managingย labeling complianceย and regulatory impacts
- Ensuring smoothย dossier submissionsย and approvals
โ Desired Skills & Qualifications
- Educational Background:ย Bachelorโs/Masterโs inย Pharmacy, Chemistry, or Life Sciences
- Experience:ย Prior experience inย Regulatory Affairs (Emerging Markets preferred)
- Technical Skills:
- Strong knowledge ofย CMC, Module 1, and eCTD submissions
- Familiarity withย Middle East & Africa regulatory guidelines
- Soft Skills:ย Excellent communication, attention to detail, and project management
๐ Why Join Jubilant Biosys?
- Work with aย globally recognized pharmaceutical leader
- Opportunities forย career growth & skill development
- Be part of aย dynamic regulatory teamย handling diverse markets
- Competitive salary & benefits