Jubilant Bhartia Group
Jubilant Bhartia Group is a global conglomerate with businesses spanning Pharmaceuticals, Life Science Ingredients, Contract Research, Food Service (QSR), Food, Auto, Aerospace Consulting, and Oilfield Services. The Group comprises four flagship companies: Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited, and Jubilant Industries Limited, employing over 56,000 people globally.
Jubilant Pharmova Limited
Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radiopharma, Allergy Immunotherapy, CDMO Sterile Injectables, Contract Research Development and Manufacturing Organization (CRDMO), Generics and Proprietary Novel Drugs businesses.
In the Radiopharma business, the Company is involved in manufacturing and supply of Radiopharmaceuticals with a network of 46 radio-pharmacies in the US. The Company’s Allergy Immunotherapy business is involved in the manufacturing and supply of allergic extracts and venom products in the US and in some other markets such as Canada, Europe and Australia. Jubilant through its CDMO Sterile Injectables business offers manufacturing services including sterile fill and finish injectables (both liquid and lyophilization), full-service ophthalmic offer (liquids, ointments & creams) and ampoules.
The CRDMO business of the Company includes the Drug Discovery Services business that provides contract research and development services through two world-class research centres in Bangalore and Noida in India and the CDMO-API business that is involved in the manufacturing of Active Pharmaceutical Ingredients. Jubilant Therapeutics is involved in Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and autoimmune disorders. The company operates six manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies.
Find out more about us at: Company Profile (jubilantpharmova.com)
Position Details
- Organization: Jubilant Generics Limited
- Designation: Senior Executive - Regulatory Affairs (RoW)
- Location: Greater Noida
- Job Summary: Drug Dossier Authoring, Reviewing & Submission drug product application, Management of Product life cycle management (LCM) activities, Assessment of changes for RoW regions to secure successful product approvals & LCM.
Key Responsibilities
- Drive drug dossier authoring, review, and submission strategy for RoW markets (LATAM/CIS/ASEAN/Africa/ME). Direct product life cycle management (LCM) activities across the assigned portfolio. Oversee assessment of post-approval changes and ensure timely, compliant execution.
- Review dossier applications, variations, renewals, and RFI responses authored by the team prior to submission to RoW Health Authorities. Coordinate with cross-functional teams (R&D, QA, ADL) to secure required regulatory data and align filing plans. Review artwork/labelling finalization against current QRD guidelines.
- Act as primary interface with R&D and other business functions to ensure project-specific regulatory strategy is defined, agreed, and delivered on time. Manage relationships with API vendors, resolving technical queries related to regulatory requirements.
- Maintain regulatory files/database.
Person Profile
- Qualification: M. Pharma or B. Pharma or PGDRA
- Experience: 3 - 5 Years
- Desired function skills: Regulatory Affairs
- Desired behavioral skills: Commitment and ownership, ability to work with agency timelines, good communication skills and proactive problem solving.
