Regulatory Affairs Pharmacist - Johannesburg - Emporium

    Emporium
    Emporium Johannesburg

    1 week ago

    Default job background
    Description

    Regulatory Affairs Pharmacist (OTC) Position at Emporium

    Location: Midrand

    Job Summary:

    The Regulatory Affairs Pharmacist (OTC) will manage work streams for assigned portfolios of products, ensuring regulatory compliance and submission of new product applications in South Africa and other applicable territories.

    • Manage work streams for- and report on the assigned portfolio of products:
    • Internal product queries from relevant departments
    • 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, with a focus on complementary medicines and medical devices.
    • Conduct dossier due diligence to ensure all data gaps are addressed, in preparation for dossier call up and registration of complementary medicines and other human medicines.
    • Prepare the registration applications for submission to the regulatory authorities
    • Work in collaboration with internal and external stakeholders to assess regulator's submissions requirements
    • Ensure the maintenance and/or update of existing registrations in accordance with the relevant legislation, regulations and guidelines for variations (CMC & Labelling), Renewals, Artwork updates etc.
    • Update and maintain databases, trackers and systems for all regulatory related activities.
    • Quality Management System: Comply with all requirements of Quality Management System to ensure Good Regulatory Practices are maintained.
    • Maintain current knowledge of relevant Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
    • Internal training and mentoring of peers when required.
    • 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.
    • Support activities such as internal audits or regulatory agency inspections
    • Ensure alignment of personal and company values

    Requirements:

    • Bachelor's Degree in Pharmacy. Diploma in Pharmacy and Registration with the South African Pharmacy Council
    • +-5 years' experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices for end-to-end regulatory activities.
    • Demonstrable experience across the product development, commercialization and maintenance lifecycle
    • Sound project management capabilities
    • Proven ability to consistently deliver to quality, time and cost standards
    • Good Manufacturing Practices (GMP)
    • Pharmaceutical production experience or exposure to supplement regulatory knowledge.

    • Experience in use of CTD software builder and compilation of eCTD dossier applications.
    • IT skills including Microsoft Office
    • Ability to prioritise and work to tight deadlines
    • Systems and operations analysis
    • Basic cost management skills
    • Active learning
    • Strategic thinking
    • Ability to cope with a high degree of complexity and change
    • Cross Functional skills: Ability to network, liaise and negotiate with others
    • Ability to set standards and objectives and monitor progress
    • Complex problem solving and decision-making skills
    • Customer relationships
    • Development of people
    • Must demonstrate responsibility, excellence and collaboration and align with Company values
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