Regulatory Affairs Officer

Jebel Ali, DU, AE, United Arab Emirates

Job Description

Experience: At least 3+ years in the same markets

Graduation in Pharmacy is a MUST.

Compilation of dossiers in Common Technical Document (CTD/eCTD) format and country specific format for emerging markets and submission via eCTD/ NeeS/ Paper.

Due diligence and updation of out sourced dossier prior to submission with Health Authorities.

Preparation and submission of all types of regulatory activities including site registration, variation, minor changes and renewal filing with Health Authorities.

Review of technical documents for regulatory adequacy, received from other departments prior to submission with Health Authorities.

Compilation of documents required for applying to various tender purposes.

Communicate with MOH officials for product submission, queries, approvals and follow-up.

Co-ordinate with related departments for the documents required for compilation of dossiers/deficiencies.

Preparation and periodic updation of various status related with regulatory department.

Archival and maintenance of regulatory related certificates and documents.

Keeping abreast of pharmacopoeias, local legislation, guidelines, industry trends, and customer practices.

Ethical, moral and professional commitments to the LIFEPharma by involving into the highest practices of regulatory profession which includes no compromise to the standard of regulatory activities, quality of medicines and the name of the organisation.

Job Type: Full-time

Pay: AED4,000.00 - AED6,500.00 per month

Application Deadline: 03/08/2024

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Job Detail

  • Job Id
    JD1717977
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Contract
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Jebel Ali, DU, AE, United Arab Emirates
  • Education
    Not mentioned