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  • Posted: Jun 29, 2022
    Deadline: Not specified
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    Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.


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    Scientific Advisor (67966)

    Job Purpose

    Support Sales, Marketing and Regulatory Team by providing strategic medical and scientific advice to drive scientific knowledge related to Medical Executive’s respective Therapeutic areas and support the Medical Executives and Drug Safety Officer with all responsibilities within Medical Affairs department for efficient functioning within the Organisation.

    Accountabilities

    1. Provide scientific assistance to Medical Executives to review business needs of Cipla Medpro and enable them to identify and bridge information gaps.
    2. Support Pharmacovigilance function as a Deputy Drug Safety Officer and assist in various activities, as required by Legislation.
    3. Regulatory Affairs
    • Compilation of clinical motivations for expedited review for SAHPRA submission
    • Approve regulatory documents to ensure regulatory compliance by the organization for package inserts, product rationales, etc.

    Education Qualification

    • A relevant University Degree in Life Sciences, Pharmaceutical or Health Sciences, or Pharmacy is required

    Relevant Work Experience

    • At least 1 year of experience in a Pharmaceutical Industry covering all areas of the function

    go to method of application »

    Regulatory Affairs Executive: SA (68336)

    Job Purpose

    Support the SAGA RA Vice President by leading and managing every aspect of new product submissions, registrations, variations, and other dossier life cycle management activities for South Africa, by ensuring high quality, timeous submissions and approvals.

    To support the SAGA RA Vice President and Management Team to manage the Regulatory Systems & Processes related to New Product Submissions, New Product Registrations, Life-Cycle management, and overall compliance within the department by ensuring that all processes and systems are in place to facilitate high quality, timeous submissions and responses are submitted to all Health Authorities. To conduct and complete administration related to the Management of these processes for all products. Gathering RA data and ensuring that systems and processes are in place for high quality data collation and statistical analysis of all RA functions across the SAGA RA environment. To assist with data analytics and provide insights that will drive improvement in both efficiencies and effectiveness within the department.

    Accountabilities

    • Provides regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and CEO to aid decision making. Provide insight into business impact and recommend strategies to adapt.
    • New dossier submissions, registrations, and life cycle management activities
    • Develops and manages stakeholder relationships
    • Cross Functional Integration support
    • Supports and enables delivery for the Regulatory Affairs Department
    • Leads and enables delivery of Systems and Processes for the SAGA Regulatory Affairs Department

    Education Qualification

    • B Pharm or higher (post graduate) scientific degree

    Relevant Work Experience

    • Min. 10 years’ experience in a regulatory affairs covering all areas of the function. At least 5 years’ experience in managing others.

    Method of Application

    Use the link(s) below to apply on company website.

     

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