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  • Posted: Nov 20, 2023
    Deadline: Not specified
  • Never pay for any CBT, test or assessment as part of any recruitment process. When in doubt, contact us

    Genedrift is a leading consultancy and solutions provider for compliance and risk services for the Life Science industry, for Regulatory Affairs and Pharmacovigilance We’ve been making the 'to-market' process faster and smarter, covering Drugs, Medical Devices, Cosmetics and Food Supplements. With operations across APAC, CIS, EU and North America, ...
    Read more about this company


    Associate - Regulatory Affairs

    • Review of labels following local HA guidelines and advise customers on the best compliance practices. 
    • Perform high-quality CMC review of technical documentation i.e. CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, and Labelling documents, for filings with HA. 
    • Attend Pre-Submission meetings with the HA and prepare post-meeting package/minutes for internal, client, and HA records. 
    • Assist in the preparation of high-quality dossiers and thereon submission to HA.
    • Adequacy Review and Gap Analysis of Technical Documentation for the CTD dossier.
    • Closure of comments with internal teams, delivery owner  and client team’s & review of additional incoming data.
    • Proper record keeping, complying with internal and client SOPs, while ensuring data security compliance.
    • Collaborate with internal teams, delivery owner and external clients for various functional/transition activities, including translation of documents, before and post submission to HA. 
    • Prepare customized reports, to suit the client's objectives. Provide regulatory intel, knowledge, and market knowledge to ensure the success of the client’s application. 
    • Supporting and enabling effective and efficient communication internally and externally to ensure operational excellence and client satisfaction.
    • Ensure the upkeep and safe custody of all original documents and records. Ensure compliance with QMS practices, while keeping all SOPs updated.
    • Stay updated and continuously update internal documentation in line with the guidelines of the HA.
    • Act as a Pharmacist-on-record/ Superintendent Pharmacist/ Director Pharmacist.

    Candidate Profile

    • Should be a pharmacist, with a valid pharmacist license, and should be able to maintain this throughout.
    • Strong project management skills
    • Excellent interpersonal skills including problem solving, oral and written communication with effective presentation skills. Excellent computer skills and comfortable with online office applications.
    • Excellent knowledge of emerging markets and a keen eye to learn
    • Flexible, Adaptive, Ability to work under pressure, work with a focus on delivery, and provide quality outputs within tight timelines.

    Experience (Yrs)

    • 3


    • Masters in Pharmacy (M. Pharm)
    • Bachelor of Pharmacy (B.Pharm)

    Method of Application

    Interested and qualified? Go to Genedrift on to apply

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