Manager-Regulatory Affairs

Job Description

Introduction: 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, Life Science Ingredients, Contract Research and Development Services, Therapeutics, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Group has global presence employing around 42,000 people across the globe with over 2,400 in North America. Jubilant Pharmova Limited Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) is a company with global presence that is involved in Radio pharma, Allergy Immunotherapy, CDMO Sterile Injectable, Contract Research Development and Manufacturing Organisation (CRDMO), Generics and Proprietary Novel Drugs businesses. In the Radio pharma 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 Injectable business offers manufacturing services including sterile fill and finish injectable (both liquid and lyophilisation), full-service ophthalmic offer (liquids, ointments and 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 www.jubilantpharmova.com . The Position Organization- Jubilant Pharmova Limited Designation - Deputy Manager / Manager - Regulatory Affairs Location- Nanjangud, Mysore Responsible for following activities of Head -Technical Services, Design and Engineering Department: Preparation/review and submission of new dossiers and updates for global markets. Preparation/review and submission of responses to queries from regulatory authorities/customers. Provide technical regulatory support to CRD for various activities (route of synthesis, starting material designation, specifications design, applied testing methodologies, Analytical method validations) related to new product development and other regulatory issues as they arise. Review of R and D technical packages for new product development (NPD) as well as cost/quality improvement process (CIP/QIP) for regulatory adequacy. Coordination with R and D to discuss on process and product controls, quality, patent and special studies to respond the queries from regulatory authorities/customers. Tracking of activities status to meet the timeline for new Submissions, Responses and Life cycle management of Dossiers. Preparation/review and submission of technical packages and open parts as per customer requirement. Review of technical packages for out sourced starting materials and intermediates for regulatory adequacy.; Review of analytical method validations, characterization data, process validations, analytical data, specifications/test methods, BMRs, packing material details, and stability data etc. w.r.t. regulatory adequacy for dossier compilation. Review of CSO/stability protocols [EDMS] and change controls (track-wise) related to facility, manufacturing process and control of materials etc. for regulatory adequacy. Attending to and lsquo;on the job trainings' and and lsquo;off the job trainings'. Updating health authority new guidelines to Regulatory affairs team. Person Profile. Education Qualification: MSc / M.Pharma,/ B.Tech / M.Tech Chemical Engineering Experienc e Range : 10+ years in API Regulatory Affairs 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. To know more about us, Please visit our LinkedIn Page- https://www.linkedin.com/company/jubilantpharmova/mycompany/