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  • Description

  • About the role

    Directing and managing the Regulatory and Clinical Affairs (RCA) department to ensure provision of and adherence to best practices relating to regulatory compliance and clinical information with respect to the manufacture, sale and appropriate clinical use of safe, quality, efficacious products in accordance with registration commitments, operational and strategic requirements and internationally accepted regulatory standards and those accepted by the South African Health Products Regulatory Authority (SAHPRA) and other regulatory agencies.

    Minimum Requirements

    B. Pharm degree

    M.Sc. Clinical Pharmacy or equivalent postgraduate degree

    Registered with the South Africa Pharmacy Council (SAPC)

    5 years’ experience in the SA pharmaceutical regulatory environment

    3 years’ experience with Medicines Information Services

    A minimum of 3 years’ experience at senior management level including leading, mentoring and coaching teams.

    A thorough understanding of the requirements of a pharmaceutical quality system and cGMP principles.

    Fully proficient in MS Office (Word, Excel, PowerPoint, Outlook)

    Good working knowledge of bibliographic management software Fully proficient in databases such as MS Access, Lotus Notes, InforMED, PCV Manager or similar.

    Clinical Trials Knowledge & Experience.

    SAP experience will be an added advantage.

    EMAIL: ***** Contact No: 031 572 3610

  • Requirements

  • Minumun level of education: Honours Degree / Post Graduate Certificate /N7
  • Years of experience: 9
  • Language(s): English
  • Availability for travel: No
  • Availability for change of residence: No
  • People with disabilities: Yes

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Job summary

  • Regulatory and Clinical Affairs Manager

  • eThekwini, KwaZulu-Natal

  • Company

    MJM Recruitment
  • Type of contract

    Permanent contract

  • Work type

    Full Time

  • Apply now