Regulatory Pharmacist at Viatris Incorporated

Viatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale. In 2022 alone, we supplied high-quality medicines to approximately 1 billion patients around the world. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. We have the ability to touch all of life’s moments, from birth to end of life, acute conditions to chronic diseases. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India.

We are recruiting to fill the position below:

Job Title: Regulatory Pharmacist

Location: Garki, Abuja
Job type: Contract
Function: Regulatory

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 Nigeria, Ghana and Mozambique.
• 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 Nigeria, Ghana and Mozambique 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 centres, 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.

Supervisory/Management Responsibilities:

• Management of the Viatris branded regulatory portfolio in Nigeria, Ghana and Mozambique ensuring all regulatory pharmacist activities (relevant licenses and inspection requirements) are adhered to per the various local regulatory bodies requirements
• Currently no direct reports, subject to change in future

Position Accountability Scope:

• Ensuring business continuity/operational excellence by maintaining the validity and integrity of all product licenses with the relevant board of health in these markets as the appointed superintendent pharmacist
• Execute all duties and uphold the regulatory compliance aspect in order to support business operations
• Financial accountability- protect market revenue
• Reports to the Head of regulatory Sub-Saharan Africa and South Africa

Qualification and Experiences

• Bachelor’s degree in Pharmacy
• MSc, MBA or PhD may be an advantage
• Experience in regulatory affairs, preferably in human medicines - minimum 5 years of experience.
• Experience in registration of products and regulatory knowledge in Nigeria, Ghana and Mozambique market guidelines, especially with site transfers.
• Demonstrate regulatory experience with a pharmaceutical company with proven examples of contribution.
• Proven ability to manage complex regulatory issues and consistently deliver to time, cost and quality standards.
• Regional regulatory experience including knowledge of NDA, multisource product applications, biosimilar submission processes and product lifecycle management processes.
• Demonstrate experience of effective delivery in a complex matrix environment.
• Knowledge of regional and global regulatory environment
• Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks.
• Knowledge of 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
• A Team player
• Growth focused
• Analytical thinking

Application Closing Date
Not Specified.