registration of medicines with the South African Health Products Regulatory Authority and the maintenance of these Responsible and accountable to the South African Health Products Regulatory Authority and the South African Pharmacy 101 of 1965) and its Amendments relating to the sale, control of the manufacturing and distribution of carried out. Accountable for the release for sale of finished product. Ensures the completion of all individual specified timelines. Forwarding of all received Product Quality Complaints, Adverse Events and Medical
and life cycle management of the assigned product(s) in product teams. Applies knowledge of current local regulatory agencies and trade associations on product and legislative development issues and monitors Provides strategic regulatory advice support for product developments regional therapy area Represents the and requirements that impact on new and existing product registrations Ensures effective collaboration across and effective submissions, approvals and other product maintenance activities Participates in skill-development
and life cycle management of the assigned product(s) in product teams. Applies knowledge of current local regulatory agencies and trade associations on product and legislative development issues and monitors Provides strategic regulatory advice support for product developments regional therapy area Represents the and requirements that impact on new and existing product registrations Ensures effective collaboration across and effective submissions, approvals and other product maintenance activities Participates in skill-development
Principals, and to control and manage a portfolio of product outputs. To ensure legal and regulatory compliance on the assigned portfolio of products: Assisting with internal product queries from relevant departments departments Assisting with external product queries from the SAHPRA, other MRA's and third-party stakeholders standards Co-ordination and submission of new product applications in South Africa and other applicable plans for the preparation and submission of new products Conduct dossier due diligence to ensure all data
the regulatory submission progress of specific products and ensure support needed to drive performance License maintenance: Ensure all post-approval product maintenance activities including CMC variations submissions, product registration or maintenance throughout the lifecycle of the product is managed effectively line with registration plan. Time to register new products vs. target and vs. industry norm. Extent of compliance non-approval or non-submission of critical variations Product labelling activities successfully completed within
Awareness, Data Protection) Forwarding of all received Product Quality Complaints, Adverse Events and Medical
Awareness, Data Protection) Forwarding of all received Product Quality Complaints, Adverse Events and Medical
projects, such as acquisitions and in-licensing of products. Drafting commercial agreements, including without
formulate and execute strategic plans and foster productive relationships, resulting in exceptional performance