Regulatory Affairs Manager - Johannesburg - MVG Recruitment Specialists

    MVG Recruitment Specialists
    MVG Recruitment Specialists Johannesburg

    2 days ago

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    Description

    About the Role

    The Regulatory Affairs Manager will lead the Regulatory team and ensure legal compliance with relevant medicine regulatory authorities, ensuring timely processing of regulatory applications.

    Key Responsibilities:

    • Manage work streams for assigned portfolios and report on progress
    • Assist internal product queries from departments
    • Respond to external product queries from SAHPRA and other stakeholders
    • Review regulatory submissions for accuracy, comprehensiveness, and compliance
    • Coordinate new product applications in South Africa and other territories
    • Develop regulatory strategies and implementation plans for product development and commercialization
    • Maintain or enhance regulatory compliance through systems, policies, and procedures

    Requirements:

    • Bachelor's degree in Pharmacy or Diploma in Pharmacy and registration with the South African Pharmacy Council
    • Minimum 5 years' experience in Regulatory Affairs, preferably in human medicines
    • Experience with CTD software builder and eCTD applications an advantage
    • Strong project management capabilities
    • Ability to deliver quality results under tight deadlines
    • Professional people management experience

    Competencies:

    • Leadership skills and personnel resource management
    • Prioritization and time management
    • Coping with complexity and change
    • Cross-functional skills: networking, liaising, and negotiation
    • Complex problem-solving and decision-making

    Desired Qualifications:

    • Bachelor's degree in Pharmacy or Diploma in Pharmacy

    Desired Work Experience:

    • 5-10 years

    Desired Qualification Level:

    • Degree


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