Posted 2 months ago

Job Description

Medical Jobs. Viatris Jobs

Role Purpose

Lead, manage, execute and provide strategic direction as the regulatory pharmacist with the regulatory management for Viatris’s branded portfolio of products in Kenya, Uganda, Tanzania and Ethiopia. Future markets could be included as well as if commercial interest becomes effective in this part of Africa.
Provide oversight for assigned countries for the branded portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions. Key focus project would be the MSA- site transfers to Viatris manufacturing sites.
To ensure regulatory input is communicated to the regional and local commercial, supply chain and quality teams for promoted and development products and the implementation of special projects.
To ensure and supervise that regulatory documentation meets relevant regulatory requirements.
To apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives.
To ensure business continuity between global regulatory strategists, country regulatory staff and distributors supporting regulatory activities on behalf of Viatris.

Key Responsibilities

Direct management of Kenya, Uganda, Tanzania and Ethiopia for the MSA project in particular. Requires close collaboration with the regulatory personnel managing the above market/reference country branded dossiers as well as working closely with the rest of the personnel in the Sub-Saharan African region.
Apply regulatory expertise for assigned countries to enable preparation of high-quality documentation and assure compliance with departmental procedures.
Maintain knowledge base of countries requirements and regulatory environments.
To build regional relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines.
Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant country plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant country business/commercial plans.
Implement team spirit/activities in alignment with Viatris’s culture and values to help retain/attract talents.
Provide input and liaise with global regulatory, CMC, supply chain, submissions management, other Viatris country offices, labelling teams, artwork centers, cluster/market, and any other key stakeholders to ensure the filing strategies are defined and executed and board of health requirements are met, ensuring a submission ready dossier. Responsible that the appropriate regulatory systems and database are updated in a timely manner when changes occur. Ensure a submission planning and forecasting tool is utilized to update timelines.
Facilitating and support all product lifecycle regulatory work, and liaise with CMC, submissions management, cluster/markets, and any other key stakeholders.
Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature.
Ensure adequate input to the local/regional Viatris commercial strategic planning process as appropriate.
Advise, where necessary, with direct reports and global regulatory leads the receipt, distribution and response to regulatory queries from target countries, consistent with procedures and including liaison with rapid response team members to ensure that response targets are met.
Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist regulatory policy with assessing the regulatory environment and identifying relevant trends.
Regularly follow up with markets and distributors, if applicable on progress of registration submission and approval activities and ensure line management are advised of progress in regulatory filings.

How to Apply

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