Associate Manager Regulatory Affairs

Dubai, United Arab Emirates

Job Description

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Summary Supports MEA Regional Director of Regulatory Affairs & Scientific Office. Ensure product regulatory compliance with applicable regulations and standards in MEA. Main responsibilities / job expectations Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
Regulatory
Operations Supports MEA Regional Director of Regulatory Affairs & Scientific Office with the following activities but not limited to:
  • Supports the coordination, compilation and submission of regulatory submissions for new and/ or renewal of registration, responses to regulatory agencies questions and other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements. Regular follow-up on submitted dossiers within responsibility. Interacts with internal and/or external stakeholders.

Ensures proper archiving for submitted and/ or approved regulatory activities in-line with effective SOPs and Ipsen s ways of working.
  • Update the applicable, internal trackers and/or database.
Education: Pharmacy bachelor\'s degree is a must. Experience: 3 - 6yrs regulatory experience in healthcare and/or pharmaceutical industry is a must. Languages: Arabic and English are must. Additional languages will be a plus. Key Technical Competencies Required Good working knowledge with Ms-Office. Good understanding of the regulations. Acts with integrity. Provides solutions to a variety of problems of limited scope and complexity. Agility.

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Job Detail

  • Job Id
    JD1651781
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Dubai, United Arab Emirates
  • Education
    Not mentioned