Regulatory Affairs / Ra Specialist (pharmaceutical)

Singapore, Singapore

Job Description

Responsibilities: * Prepare and maintain a listing of all registered products in all markets, locally and globally, and maintain its renewal in a timely manner. * Keeping track of legislation ch Responsibilities: Prepare and maintain a listing of all registered products in all markets, locally and globally, and maintain its renewal in a timely manner. Keeping track of legislation changes and advise on the legal and scientific restraint and requirements, collect, collate and evaluate scientific data. Ensure local and international market regulatory requirements are in compliance (HSA, TGA, FDA, EU, others as applicable). Participate in regulatory inspection by the regulatory authorities and certification bodies. Participate and assist to provide material/information required by Regulatory Authority for import, reimbursement and product registration. Ensure all technical documents are updated and ready for regulatory submission. Update when necessary. Working closely with market Authorized Representative to ensure products marketed are safe, sterile and effective. Any other tasks or projects that are being assigned by the immediate supervisor, as and when required. Requirements: Min. possess a Diploma/Degree in Life Science (Pharmacy, Biology, Chemistry, Pharmaceutical). Min. 2 years of related experience and min. 5 years of related experience for Senior/Manager position. In-depth knowledge of the cGMP, market regulations (HSA, FDA, TGA, CFDA, EU) and ISO 13485. Understanding of law, regulation and pending regulation. Good communication, technical writing and interpersonal skills. How to Apply: Interested candidates, please submit your updated resume in MSWORD format by using Apply Now button .We regret to inform that only shortlisted candidates will be informed.. Sarah Sevilla Registration Number: R22107553 EA License No: 18C9027

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Job Detail

  • Job Id
    JD1188234
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    $42000 - 60000 per year
  • Employment Status
    Permanent
  • Job Location
    Singapore, Singapore
  • Education
    Not mentioned