Regulatory Affairs Pharmacist - Midrand - Emporium Human Capital

    Emporium Human Capital
    Emporium Human Capital Midrand

    4 days ago

    Emporium Human Capital background
    Description

    Regulatory Affairs Pharmacist OTC POS24203

    Based: Midrand

    Salary: R750K

    Qualifications/Experience:

    • Bachelors degree in Pharmacy/Diploma in Pharmacy and Registration with the South African Pharmacy Council
    • 3 to 5 years experience in Regulatory Affairs, preferably in human medicines
    • 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

    Key Job Outputs:

    • Manage work streams for and report on the assigned portfolio of products:
    • Assisting with internal product queries from relevant departments
    • Assisting with external product queries from the SAHPRA, other MRAs 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 internal and external stakeholders to assess regulators 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.
    • Support activities such as internal audits or regulatory agency inspections
    • Ensure alignment of personal and company values
    • Core Competencies:
    • Experience in use of CTD software builder and compilation of eCTD applications.
    • IT skills
    • 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
    • Interested parties who meet the above requirements must apply

    Company Values:

    • We value innovation and creativity
    • We value teamwork and collaboration
    • We value integrity and ethics
    • We value continuous learning and professional growth

    Contact Information:

    Please submit your application via our website

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