Regulatory Affairs Pharmacist

SUMMARY:
Isando,Kempton Park

POSITION INFO:

Minimum Requirements:

Bachelor’s degree in Pharmacy, registered with the South African Pharmacy Council

• 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 on South Africa, Botswana, Namibia, Mauritius, Zambia, Zimbabwe and Malawi market guidelines.

Position Summary and Objective:

Lead, manage, execute and provide strategic direction as the regulatory affairs pharmacist registered with the South African Pharmacy Council with the regulatory management of South Africa and South Africa downstream markets Botswana, Namibia, Mauritius, Zambia, Zimbabwe and Malawi for Viatris’s branded portfolio of products. Future markets could be included as well as if regulatory pathways become effective in Lesotho, Seychelles and Swaziland.

• Provide oversight for assigned countries for the branded Upjohn portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions. • 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 the Company.