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    Regulatory Affairs - United Kingdom - PharmaGroww

    PharmaGroww
    PharmaGroww United Kingdom

    1 week ago

    Default job background
    Description

    Jubilant Pharma Limited is a global integrated pharmaceutical company offering a wide range of products and services to its customers across geographies.

    We organise our business into two segments, namely, Specialty Pharmaceuticals, comprising Radiopharmaceuticals (including Radio pharmacies), Contract Manufacturing of Sterile Injectable, Non-sterile & Allergy Therapy Products, and Generics & APIs, comprising Solid Dosage Formulations & Active Pharmaceutical Ingredients.

    JGL in India has Research & Development units at Noida and Mysore.

    It has two manufacturing facilities one at Mysore, Karnataka and another at Roorkee, Uttarakhand, engaged in APIs and Dosage manufacturing, respectively.

    The manufacturing location at Mysore is spread over 69 acres and it's a USFDA approved site engaged in manufacturing of APIs, and caters to the sales worldwide.

    The company is the market leader in four APIs and is amongst the top three players for another three APIs in its portfolio helping it maintain a high contribution margin.

    The manufacturing location at Roorkee, Uttarakhand is state of the art facility and is audited and approved by USFDA, Japan PMDA, UK MHRA, TGA, WHO and Brazil ANVISA.

    Both manufacturing units are backward- integrated and are supported by around 500 research and development professionals based at Noida and Mysore.

    R&D works on Development of new products in API, Solid Dosage Formulations of Oral Solid, Sterile Injectable, Semi-Solids Ointments, Creams and Liquids.

    All BA/BE studies are done In house at our 80 Bed facility which is inspected and having approvals /certifications from The Drugs Controller General (India) and has global regulatory accreditations including USFDA, EMEA, ANVISA (Brazil), INFRAMED (Portugal Authority), NPRA(Malaysia), AGES MEA (Austria) for GCP and NABL, CAP accreditations for Path lab services.

    JGL's full-fledged Regulatory Affairs & IPR professionals ensures unique portfolio of patents and product filings in regulatory and non-regulatory market.

    Revenue of Jubilant Pharma is constantly increasing and during the Financial Year it was INR 53,240 Million as compared to INR 39,950 Million during the Financial Year
    Authoring of Module 1 along with quality modules
    Assessments of post approval changes, life-cycle maintenance and ensure timely post approval regulatory activities
    Coordinate with cross-functional teams for desired regulatory data and accordingly plan & complete regulatory filing activities
    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
    Maintain regulatory files/database

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