Fiona Smith Email & Phone Number

Johannesburg, Gp, Za

Johannesburg Area, South Africa

Responsibilities:o Report into Director Regulatory Affairs: South Africa and EPA.o Ensure timely preparation, submission and appropriate follow-up of new Marketing Authorisation Applications to the Health Authorities for assigned products.o Countries: Angola, Botswana, Ethiopia, Ghana, Kenya, Malawi, Namibia, Nigeria, Tanzania, Uganda, Zambia and Zimbabwe. o Submission of pharmaceutical variations, safety label updates and renewal applications to relevant countries within the MSD stipulated timelines.o Accurate and compliant labelling translations and artwork preparation.o Remain updated on latest MSD pipeline filings, relevant regional and local regulations and guidelines.o Collect regulatory information (regulatory intelligence).o Works alongside Business Development, locally, regionally and globally, to support business initiatives in the sub region.o Manage the relationships with internal and external regulatory contacts on a sub-regional, regional and global level.o Management of applicable regulatory personnel in EPA. o Substitute for Country Lead Regulatory Affairs as and when it is appropriate.Marketing Authorisations and Lifecycle Management:o Submission and approval of assigned new Marketing Authorisation applications in close co-operation with relevant Management, Medical, Finance, Customer Service, Marketing and external affairs departments, MSD Regulatory affairs on a sub-regional, regional and global level, as well as with local Health Authorities as appropriate, depending on procedure type. o Manage responses to questions raised by the Health Authorities on new product submissions and variations.o Interact with the Health Authorities and Local Technical Representatives (LTRs) in each country, with continuous interface with MSD regional liaisons.o Maintenance of product lifecycle management for assigned products.o Complianceo Labelling and artworko Cross-functional activitieso Regulatory environmento Quality

Johannesburg Area, South Africa

My current responsibilities include oversight of all regulatory activities carried out by the CHC RA team to ensure regulatory compliance. I have successfully directed the completion of numerous projects within specific timeframes, including the MBR1 to CTD dossier conversion project. With well-refined organisational skills, I coordinate the drafting of schedules for various countries in line with objectives set by management. I lead and train team members, develop relationships with cross-functional departments and engage with stakeholders to increase interaction.

Johannesburg Area, South Africa

Working as a regulatory affairs manager, I supervised the processes carried out by the team. My focus was on Prescription Medicine and Consumer Healthcare Medicine. In collaboration with my team members, we completed more than 70 new product registrations in countries including Ghana, Kenya, Mauritius and Nigeria. I was responsible for bi-annual performance reviews and coordination of new product submissions.

Johannesburg Area, South Africa

Regulatory Affairs Team Leader

Johannesburg Area, South Africa

Regulatory Affairs Pharmacist (South Africa, Namibia, Botswana then in 2008 changed countries to Kenya, Nigeria and Uganda) (Prescription Medicine and Consumer Healthcare Medicine)

Johannesburg Area, South Africa

Johannesburg Area, South Africa

I held various positions in various retail pharmacy from Junior Pharmacist to Pharmacy Manager.

Johannesburg Area, South Africa

Internship

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences

First Year B. Pharm (Biological Science, Latin And It)

Bachelor Of Science - Bs, Bsc Microbiology

Matriculated