Regulatory Affairs Pharmacist Johannesburg - Vela Personnel

    Vela Personnel
    Vela Personnel Johannesburg

    2 days ago

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    Description

    Senior Regulatory Affairs Pharmacist

    A multinational pharmaceutical organisation seeks a Senior Regulatory Affairs Pharmacist to manage regulatory activities for South Africa and Southern Africa markets.

    Duties & Responsibilities

    Key job outputs:

    • Manage regulatory affairs for allocated generic portfolio products in South Africa and Southern Africa markets, including future markets and harmonisation opportunities.
    • Oversight of assigned countries for the portfolio, developing and executing regulatory strategies, processes, and plans for new registrations and post-approval submissions.
    • Communicate regulatory input to regional and local Commercial, Supply Chain, and Quality teams for promoted and development products, and implement special projects.
    • Evaluate and ensure regulatory documentation meets relevant requirements.
    • Apply knowledge of regulatory requirements to facilitate efficient registration of medicinal products consistent with commercial objectives.
    • Ensure business continuity between Global Regulatory Strategists, Country Regulatory staff, and distributors supporting regulatory activities on behalf of the Company.
    • Direct management of part of the portfolio for South Africa and Southern Africa markets, requiring close collaboration with Sub-Saharan African region regulatory personnel.
    • Apply regulatory expertise to enable preparation of high-quality documentation and assure compliance with departmental procedures.
    • Maintain knowledge base of countries' requirements and regulatory environments.
    • Build regional relationships with stakeholders/partners and assist team members to establish similar relationships with local stakeholders/partners, ensuring clarity of regulatory strategy and timelines.
    • Manage performance of direct reports (where applicable) to achieve agreed objectives and identify training and development needs.
    • Contribute to the regulatory strategy for product development, ensuring alignment with business objectives and country plans.
    • Promote team spirit and activities aligned with the company's culture and values to retain/attract talents.
    • Collaborate with Global Regulatory, Regulatory Science/CMC, Supply Chain, Submissions Management, and other key stakeholders to define and execute filing strategies, ensuring Board of Health requirements are met.
    • Facilitate and support product lifecycle regulatory work, liaising with Regulatory Science/CMC, Submissions Management, Cluster/Markets, and key stakeholders.
    • Evaluate and develop regulatory strategies and plans for assigned countries, reviewing existing guidelines and literature.
    • Provide input to local/regional commercial strategic planning process as necessary.
    • Advise on receipt, distribution, and response to regulatory queries from target countries, consistent with procedures.
    • Develop detailed understanding of regulatory guidelines and technical requirements, maintaining the regulatory requirements database, and assisting Regulatory Policy with assessing the regulatory environment.
    • Frequently follow up with markets and distributors on registration submission and approval activities, informing line management of progress in regulatory filings.

    Desired Experience & Qualification

    Qualifications:

    • Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council.
    • MSc, MBA or PhD may be an advantage.

    Experience:

    • Minimum 8 years of experience in regulatory affairs, preferably in human medicines.
    • Registration experience in South Africa, Botswana, and Namibia market guidelines.
    • Demonstrated regulatory experience with a pharmaceutical company, with proven examples of contributions.
    • Proven ability to manage complex Regulatory issues and deliver results within time, cost, and quality standards.
    • Regional Regulatory experience, including knowledge of NDA, multisource product applications, and product lifecycle management processes.
    • Effective delivery in a complex matrix environment.
    • Knowledge of Regional Regulatory environment.
    • Understanding of CMC submissions, drug development, regulations, and guidelines.
    • Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills.
    • Understanding of pharmaceutical industry, clinical trials, and pharmacovigilance.
    • Knowledge and understanding of quality systems, processes, audit, and inspection.
    • Ability to influence at all levels in the organization.
    • Able to simplify complex ideas and processes.
    • Team player.
    • Growth focused.
    • Analytical thinking.
    • Change agile.

    Remuneration

    Salary: Market related.

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