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  • Senior Regulatory Affairs Pharmacist Market related - Johannesburg - Vela Personnel

    Vela Personnel
    Vela Personnel Johannesburg

    1 week ago

    Default job background
    Description

    Senior Regulatory Affairs Pharmacist

    A multinational pharmaceutical organisation is seeking a Senior Regulatory Affairs Pharmacist to oversee regulatory management of South Africa and some Southern Africa markets like Botswana and Namibia for an allocated part of the company's generic portfolio of products.

    Duties & Responsibilities

    • Responsible for regulatory management of assigned countries, providing oversight for strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post-approval submissions.
    • Ensure regulatory input is communicated to regional and local teams for promoted and development products, and implement special projects.
    • Supervise the preparation of regulatory documentation to meet relevant regulatory requirements.
    • Apply knowledge and best interpretation of regulatory requirements to enable efficient and effective registration of medicinal products consistent with commercial objectives.
    • Maintain business continuity between global and local regulatory teams, ensuring compliance with departmental procedures.
    • Direct management of part of the portfolio requires close collaboration with regional regulatory staff and distributors.
    • Apply regulatory expertise to ensure high-quality documentation and assure compliance with departmental procedures.
    • Maintain a knowledge base of countries' requirements and regulatory environments.
    • Build regional relationships with stakeholders/partners and assist team members to do the same with local stakeholders/partners, ensuring communication/clarity of regulatory strategy and timelines.
    • Manage the performance of direct reports to achieve agreed objectives and identify training and development needs.
    • Provide input to regulatory strategy for product development, ensuring alignment with business objectives and country plans.
    • Promote team spirit/activities aligned with the company's culture and values to retain/attract talents.
    • Collaborate with global regulatory, science/CMC, supply chain, submissions management, and other key stakeholders to ensure filing strategies are defined and executed.
    • Facilitate product lifecycle regulatory work and liaise with key stakeholders.
    • Prepare regulatory strategies and plans for assigned countries, including review of existing guidelines and literature.

    Desired Experience & Qualification

    • Bachelor's degree in Pharmacy, registered with the South African Pharmacy Council.
    • MSc, MBA or PhD may be an advantage.
    • At least 8 years of experience in regulatory affairs, preferably in human medicines.
    • Experience in registration of products and regulatory knowledge on South Africa, Botswana, and Namibia market guidelines.
    • Demonstrate regulatory experience with a pharmaceutical company and proven examples of contribution.
    • Proven ability to manage complex Regulatory issues and deliver to 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.
    • Technically competent in CMC submissions, interpret and communicate requirements, and identify potential risks.
    • Knowledge of drug development, regulations, and guidelines.
    • Strong leadership and management qualities, excellent communication, negotiation, and interpersonal skills.
    • Understanding of pharmaceutical industry, clinical trials, and pharmacovigilance.
    • Knowledge and understanding of quality systems, processes, audit, and inspection.
    • Influence at all levels in the organization.
    • Simplify complex ideas and processes.
    • Team player.
    • Growth focused.
    • Analytical thinking.
    • Change agile.

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