Senior Regulatory Affairs Pharmacist: OTC - Midrand - Emporium Human Capital

    Emporium Human Capital
    Emporium Human Capital Midrand

    5 days ago

    Emporium Human Capital background
    Description

    Job Title: Senior Regulatory Affairs Pharmacist (OTC)

    Location: Midrand

    Overview:

    We are seeking a highly skilled and experienced Senior Regulatory Affairs Pharmacist to join our team at Emporium Human Capital. The successful candidate will be responsible for managing work streams, establishing regulatory priorities, and allocating resources and workloads.

    Key Responsibilities:

    • Manage work streams for assigned portfolio of products, including internal product queries from relevant departments and external product queries from the SAHPRA and other MRAs.
    • Establish regulatory priorities and allocate resources and workloads.
    • Review regulatory agency submissions to ensure timelines, accuracy, comprehensiveness, or compliance with regulatory standards.
    • Coordinate and submit new product applications in South Africa and other applicable territories.
    • 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 registration applications for submission to regulatory authorities.
    • Work collaboratively with internal and external stakeholders to assess regulators' submission requirements.
    • Maintain existing registrations in accordance with relevant legislation, regulations, and guidelines.
    • Update and maintain databases, trackers, and systems for all regulatory-related activities.

    Requirements:

    • Bachelor's Degree in Pharmacy and Diploma in Pharmacy, with Registration with the South African Pharmacy Council.
    • Minimum 5 years of experience in Regulatory Affairs, preferably in human medicines, including complementary medicines and medical devices.
    • 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) knowledge.
    • Pharmaceutical production experience or exposure to supplement regulatory knowledge.

    Core Competencies:

    • Experience in using CTD software builder and compilation of eCTD dossier applications.
    • IT skills, including Microsoft Office.
    • Ability to prioritize and work to tight deadlines.
    • Systems and operations analysis.
    • Basic cost management skills.
    • Active learning.
    • Strategic thinking.
    • Complex problem-solving and decision-making skills.
    • Cross-Functional skills: Ability to network, liaise, and negotiate with others.

    Working Relationships:

    The successful candidate will be required to establish and maintain effective relationships with Regulatory Authorities, internal, and external stakeholders.

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