Are you an aspiring professional in the pharmaceutical industry looking for your next big opportunity? Jubilant Pharma Limited, a global leader in integrated pharmaceutical solutions, is hiring an Executive – Regulatory Affairs to join its dynamic team. If you’re passionate about regulatory compliance, product filings, and contributing to a company that’s shaping the future of healthcare, this could be your dream job! Read on to learn more about this exciting role, the company, and how you can apply.
About Jubilant Pharma Limited
Jubilant Pharma Limited is a powerhouse in the global pharmaceutical sector, delivering innovative products and services across multiple geographies. The company operates through two key segments: Specialty Pharmaceuticals (Radiopharmaceuticals, Contract Manufacturing of Sterile Injectables, Non-Sterile Products, and Allergy Therapy Products) and Generics & APIs (Solid Dosage Formulations and Active Pharmaceutical Ingredients).
Its wholly-owned subsidiary, Jubilant Generics (JGL), drives innovation with R&D hubs in Noida and Mysore, India, and state-of-the-art manufacturing facilities in Mysore, Karnataka (API production), and Roorkee, Uttarakhand (Dosage manufacturing). Both sites are backward-integrated and supported by over 500 R&D professionals, ensuring cutting-edge development in APIs, oral solids, sterile injectables, ointments, creams, and liquids.
With a revenue of INR 53,240 Million in FY 2018-19 (up from INR 39,950 Million in FY 2017-18), Jubilant Pharma is on a steep growth trajectory, making it an exciting time to join the organization. For more details, visit www.jubilantpharma.com.
Job Role: Executive – Regulatory Affairs
As an Executive – Regulatory Affairs, you’ll play a pivotal role in ensuring Jubilant Pharma’s products meet stringent global regulatory standards. This position is ideal for professionals with expertise in regulatory filings, compliance, and intellectual property rights (IPR) within the pharmaceutical industry.
Key Responsibilities
- Prepare and submit regulatory filings for APIs, solid dosage formulations, and sterile injectables in regulatory and non-regulatory markets.
- Collaborate with R&D teams in Noida and Mysore to support product development and compliance.
- Ensure adherence to guidelines from global regulatory bodies like USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA.
- Manage intellectual property rights (IPR) and contribute to Jubilant Pharma’s unique patent portfolio.
- Support audits and inspections at manufacturing facilities in Mysore and Roorkee.
Why This Role Matters
Jubilant Pharma’s regulatory affairs team is at the heart of its success, ensuring that innovative products reach markets worldwide. With a focus on lifestyle-driven therapeutic areas like Cardiovascular (CVS) and Central Nervous System (CNS), your work will directly impact global healthcare.
Why Join Jubilant Pharma?
1. World-Class Facilities
- Mysore Facility: A 69-acre, USFDA-approved site specializing in APIs for global markets. It’s a market leader in four APIs and among the top three players for three others.
- Roorkee Facility: A cutting-edge, multi-audited plant (USFDA, Japan PMDA, UK MHRA, etc.) focusing on B2B dosage manufacturing for EU, Canada, and emerging markets.
2. Robust R&D Backbone
With around 500 R&D professionals and an in-house 80-bed BA/BE (Bioavailability/Bioequivalence) facility, Jubilant Pharma ensures all studies meet global standards (approved by USFDA, EMEA, ANVISA, and more).
3. Growth Opportunities
Jubilant Pharma’s increasing revenue and global footprint mean ample opportunities for career advancement in the pharmaceutical industry.
Who Should Apply?
Qualifications & Skills
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
- Experience in regulatory affairs within the pharmaceutical sector (preferred).
- Knowledge of global regulatory guidelines (USFDA, WHO, etc.).
- Strong analytical skills and attention to detail.
- Excellent communication and teamwork abilities.
Location
This role is likely based at one of Jubilant Pharma’s key locations in India (Noida, Mysore, or Roorkee), though specific details will be shared during the application process.
