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Executive Regulatory Affairs

2.00 to 4.00 Years   Ahmedabad   05 Feb, 2022
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaLiasion
EmploymentTypeFull-time

Job Description

    • 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
    • Collect, collate, and evaluate scientific data from a range of sources
    • Develop and write clear arguments and explanations for new product licenses and license renewals
    • Prepare submissions of license variations and renewals to strict deadlines
    • Monitor and set timelines for license variations and renewal approvals
    • Write clear, accessible product labels and patient information leaflets
    • 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
    • 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 authorization
    • Take part in the development of marketing concepts and approve packaging and advertising before a products release.

Keyskills :
regulatoryregulatory affairsregulatory compliance managementregulatory complianceregulatory auditregulatory reportingliaison

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