Jubilant Pharma Limited, a global leader in the pharmaceutical industry, is seeking a highly motivated and skilled Executive – Regulatory Affairs to join its dynamic team. This role is critical in ensuring compliance with global regulatory standards and driving the successful registration of products across international markets.
As an Executive – Regulatory Affairs, you will be responsible for:
- Preparing, reviewing, and submitting regulatory documents to global health authorities (e.g., USFDA, EMA, WHO, etc.).
- Ensuring compliance with regulatory requirements for APIs and dosage formulations.
- Coordinating with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to compile necessary documentation.
- Keeping abreast of changes in regulatory guidelines and implementing necessary updates.
- Supporting the preparation of dossiers for product registrations in regulated and semi-regulated markets.
- Assisting in addressing queries from regulatory agencies during the approval process.
- Contributing to the development and maintenance of regulatory strategies for new and existing products.
About Jubilant Pharma Limited
Jubilant Pharma Limited is a globally integrated pharmaceutical company with a strong presence in Specialty Pharmaceuticals and Generics & APIs. The company operates through two key segments:
- Specialty Pharmaceuticals: Includes Radiopharmaceuticals, Contract Manufacturing of Sterile Injectables, Non-sterile Products, and Allergy Therapy.
- Generics & APIs: Focuses on Solid Dosage Formulations and Active Pharmaceutical Ingredients (APIs).
Jubilant Generics Limited (JGL), a wholly-owned subsidiary of Jubilant Pharma, is a key player in the generics market. With state-of-the-art manufacturing facilities in Mysore and Roorkee, JGL is approved by major regulatory bodies, including USFDA, Japan PMDA, UK MHRA, TGA, WHO, and Brazil ANVISA.
The company’s R&D centers in Noida and Mysore are supported by over 500 professionals, working on innovative products across APIs, Solid Dosage Formulations, Sterile Injectables, and more. Jubilant Pharma’s revenue has shown consistent growth, reaching INR 53,240 Million in FY 2018-19, up from INR 39,950 Million in FY 2017-18.
Key Responsibilities
- Prepare and submit regulatory filings for global markets.
- Ensure compliance with regulatory guidelines and standards.
- Collaborate with internal teams to gather and compile required documentation.
- Monitor and implement changes in regulatory policies.
- Address regulatory queries and ensure timely approvals.
- Support the development of regulatory strategies for product lifecycle management.
Qualifications and Skills
- Bachelor’s or Master’s degree in Pharmacy, Chemistry, or Life Sciences.
- 2-5 years of experience in Regulatory Affairs within the pharmaceutical industry.
- Strong knowledge of global regulatory guidelines (USFDA, EMA, WHO, etc.).
- Excellent communication and interpersonal skills.
- Attention to detail and ability to manage multiple projects simultaneously.
- Proficiency in regulatory documentation and dossier preparation.
Why Join Jubilant Pharma?
- Be part of a globally recognized pharmaceutical leader.
- Work in state-of-the-art facilities approved by top regulatory agencies.
- Collaborate with a team of 500+ R&D professionals driving innovation.
- Contribute to a portfolio of market-leading APIs and dosage formulations.
- Enjoy opportunities for professional growth and development.
