Job Title

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 43,000 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 Organisation (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 () The Position : Organization: Jubilant Generics Limited Designation: Assistant Manager - Drug Regulatory Affairs (US) / Formulations Location: Greater Noida, Uttar Pradesh, India Job Summary: Drug dossier authoring, reviewing & submission drug product application. Management of product life cycle management (LCM) activities. Assessment of post approval changes to secure successful product approvals & LCM. Thorough knowledge of CMC requirements, labelling requirements, regulatory impact of post approval changes and regulatory life cycle management. Key Responsibilities : Drug dossier authoring, reviewing & submission of ANDAs (US). Product life cycle management (LCM) activities. Assessment of post approval changes. eCTD publishing. Thorough knowledge of CMC and Module 1 requirements. DMF review and assessment, Query evaluation and response for under review ANDAs within timeline. Assessments of post approval changes and submissions (Annual report, CBE-30, PAS), life-cycle maintenance and ensure timely post approval regulatory activities. Artworks (PIL, labels) and labeling files preparation, submission along with SPL preparation. Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities. Review and finalization of artwork / label as per current guideline. Regulatory Intelligence and develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends. Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in timely manner. Co-ordination with API vendors to resolve technical quires w.r.t. regulatory requirements. To review technical documents like process validation, AMV, Stability and composition etc. received from Site QA or R&D / ADL against DMF / Dossier requirements. Maintain regulatory files / database. Person Profile : Qualification: Master / Bachelor’s degree in Pharmacy. Experience: 3-5 Years of experience in Regulatory Affairs for US market. Desired Skills & Must Have: 3-5 years of relevant experience in Pharma Industry only. Minimum 3 years with knowledge of Regulatory Affairs from Regulated Market is preferred. Commitment & ownership. Ability to work with Agency time lines. Good communication skills. Proactive problem solving. NOTE : Jubilant is an equal opportunity 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.