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Regulatory Affairs Officer

Fresher   Meerut   16 Jul, 2025
Job LocationMeerut
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

    ResponsibilitiesAs a regulatory affairs officer, youll need to:
    • ensure that a companys products comply with the regulations of the regions where they want to distribute them
    • keep up to date with national and international legislation, guidelines and customer practices
    • respond to queries from medical bodies like the CDSCO,Medicines and Healthcare products Regulatory Agency (MHRA)
    • collect, collate and evaluate scientific data from a range of sources
    • develop and write clear arguments and explanations for new product licences and licence renewals
    • prepare submissions of licence variations and renewals to strict deadlines
    • monitor and set timelines for licence variations and renewal approvals
    • work with specialist computer software and resources
    • write clear, accessible product labels and information leaflets
    • plan and develop product trials and interpret trial data
    • advise scientists and manufacturers on regulatory requirements
    • provide strategic advice to senior management throughout the development of a new product
    • project manage teams of colleagues involved with the development of new products
    • oversee product trials and interpret trail data
    • undertake and manage regulatory inspections
    • review company practices and provide advice on changes to systems
    • liaise with, and make presentations to, regulatory authorities
    • negotiate with regulatory authorities for marketing authorisation
    • take part in the development of marketing concepts and approve packaging and advertising before a products release.

Keyskills :
analytical skillsregulatory affairs

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