Participate in manufacturing authorization processes of the facility, marketing authorization processes of the finished products, pharmacovigilance processes and support compliance to other regulatory requirements

Ensuring implementation of company quality policy.
Work towards achieving defined quality objectives
Preparation and submission of dossiers for marketing authorization applications.
Preparation and submission of additional information as may be requested by regulatory authorities.
Preparation and submission of variation applications to registered products.
Preparation and submission of applications for manufacturing Licenses.
Keeping up to date with changes in regulatory legislation and guidelines.
Maintaining and monitoring/follow up on registration status of all products country wise.
Maintaining regulatory compliances to pharmacovigilance requirements.
Addressing regulatory Authorities related pharmacovigilance queries.
Execution of pharmacovigilance activities such as Medical Information Call Center (MICC), Individual Case Safety Report (ICSR), Periodic Benefit Risk Evaluation Reports (PBRER), signal detection.
aggregate reporting, label review and regulatory intelligence activity.
Ensure Safety Data Exchange Agreements (SDEAs) are signed between partners and Apdl for businesses in Uganda & as appropriate.
Participate in Pharmacovigilance-inhouse training as applicable
Preparing and maintaining regulatory documentation.
Ensure safety of classified information
Ensure that any other duty assigned by HOD is executed