Regulatory Affairs Manager - Johannesburg, South Africa - Emporium

    Emporium
    Emporium Johannesburg, South Africa

    3 weeks ago

    Default job background
    Full time
    Description

    Regulatory Affairs Manager (Critical Care) POS24104

    Aeroton/ Crown mines

    R per annum

    PURPOSE OF THE JOB

    Lead the Regulatory team to provide superior Regulatory services to relevant departments within the company and with external partners and Principals, and to control and manage portfolio and team outputs. To ensure legal compliance with the relevant medicine Regulatory Authorities (Country Specific where applicable), Medicines and Related Substances Control Act and South African Pharmacy Council, ensuring timeous processing of regulatory applications.

    REQUIREMENTS:

    • Bachelor's degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
    • Minimum of 5 years' experience in Regulatory Affairs, preferably in human medicines. Demonstrated experience across the product development, commercialization and maintenance lifecycle
    • Sound project management capabilities
    • Proven ability to consistently deliver to quality, time and cost standards
    • Professional people management experience

    Key Job Outputs

    • Manage work streams for- and report on the assigned group of portfolios

    Assisting with internal product queries from relevant departments

    Assisting with external product queries from the SAHPRA, other MRA's and third-party stakeholders

    Establish regulatory priorities and allocate resources and workloads

    Review regulatory agency submission of materials to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards

    • Co-ordination and submission of new product applications in South Africa and other applicable territories, including but not limited to

    Develop regulatory strategies and implementation plans for the preparation and submission of new products

    Conduct dossier due diligence to ensure all data gaps are addressed

    Prepare the registration applications for submission to the regulatory authorities

    Work in collaboration with NBD to assess regulator's submissions requirements

    • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines
    • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
    • Internal training and mentoring
    • Establish and maintain effective relationships with Regulatory Authorities, internal and external stakeholders
    • Formulate or implement regulatory affairs systems, policies and procedures to ensure that regulatory compliance is maintained or enhanced.
    • Manage activities such as internal audits or regulatory agency inspections
    • Ensure alignment of personal and company values

    Closing Date: 12 April 2024

    To apply please send CVs to and use "POS24102" or "Regulatory Affairs Manager" as reference.

    Please note that only shortlisted candidates will be contacted.