Jubilant Bhartia Group

Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 56,000 employees.

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:Manager - Regulatory Affairs (UK / EU)
- Location: Greater Noida, Uttar Pradesh
- Job Summary: To lead the regulatory strategy for new submissions, submission planning and lifecycle management of drug product dossiers for Europe, UK, Australia and Canada markets. This role combines hands-on regulatory expertise with people leadership, owning both the quality of regulatory output and the performance and development of the team delivering it.
- Challenges: Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management.

Key Responsibilities:

Europe / UK:

- Own and drive drug dossier authoring, review, and submission strategy for EU (DCP/MRP/NP), UK, Australia, and Canada markets.
- Direct product life cycle management (LCM) activities across the assigned portfolio.
- Oversee assessment of post-approval changes and ensure timely, compliant execution.
- Own eCTD publishing standards and compliance across all submissions.
- Maintain and ensure team-wide expert-level knowledge of CMC and Module 1 requirements.

Preparation & Submission:

- Review and approve dossier applications, variations, renewals, and RFI responses authored by the team prior to submission to EU, UK, Australia, and Canada Health Authorities.
- Oversee authoring quality for Module 1 and quality modules across the team.




- Direct assessment of post-approval changes and lifecycle maintenance; ensure regulatory filing timelines are met.
- Coordinate with cross-functional teams (R&D;, QA, ADL) to secure required regulatory data and align filing plans.
- Review and approve artwork/labelling finalization against current QRD guidelines.
- Own the regulatory intelligence function — ensure the team tracks and applies current technical guidelines, regulatory requirements, and emerging trends.

Coordination:

- 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.
- Review technical documents (process validation, AMV, stability, composition, etc.) from Site QA, R&D;, and ADL against DMF/dossier requirements, and escalate gaps.
- Represent Regulatory Affairs in leadership and project review meetings; report status, risks, and mitigation plans to senior management.

Reporting & Maintenance:

- Maintain regulatory files/database

Person Profile:

- Qualification: Master / Bachelor's degree in Pharmacy
- Desired Certifications: PGDRA
- Experience: 10-12 years of regulatory experience with large/midsized pharma companies.
- Desired function skills: Well versed with latest regulatory guidelines.
- Desired behavioral skills: Team handling exposure, commitment & ownership, robust communication, problem solving skills and ability to work with the agency timelines.

Jubilant is an equal prospect employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances.

📌 Manager Regulatory Affairs (Noida)
🏢 JUBILANT GENERICS
📍 Noida