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Senior Regulatory Affairs Pharmacist

Senior Regulatory Affairs Pharmacist

OttoBauthenticJohannesburg, South Africa
30+ days ago
Job description

MAIN PURPOSE OF JOB

  • Medicines Registration and Maintenance of Product Licenses with various Health Authorities in African countries

CORE KEY AREAS

  • Submission of new pharmaceutical products for registration
  • Renewals of pharmaceutical products
  • Maintenance of registrations

    • RESPONSIBILITIES

  • Evaluate the dossier or variation documents and complete a gap analysis
  • On receipt of additional data (if required), compile the application for submission in accordance with the requirements for such applications, prescribed by the Health Authority(HA)
  • Create a complete electronic copy of the application
  • Submit the application (with samples if required) to the HA
  • Attend to subsequent correspondence from the HA to address any requests for additional information within deadlines specified.
  • Ensure product records / databases are updated in line with good documentation practices and company requirements.
  • Review the impact of planned changes on registrations
  • Review of printed packaging for compliance with legislated requirements all affected markets
  • Review of marketing material in compliance with the marketing code and country specific regulatory requirements
  • Any other task relevant to the RA department as requested by management

    • QUALIFICATIONS & EXPERIENCE

  • B. Pharm Degree
  • 3-5 years experience in pharmaceutical regulatory affairs (SADC, EAC preferred)
  • Knowledge of relevant medicine legislation and guidelines
  • Ability to read regulatory authority guidelines, assimilate and interpret this data to provide accurate, succinct submissions.
  • Ability to argue scientifically where sufficient justification exists to request exemption from certain requirements stated in guidelines.
  • Ability to work independently
  • Ability to follow instructions
  • Excellent computer skills (Microsoft word, adobe, excel).
  • Ability to produce high quality documents.
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    Pharmacist • Johannesburg, South Africa