REF: REGULATORY AFFAIRS SPECIALIST AND DEPUTY LOCAL SAFETY OFFICER
Duties and responsibilities Product dossier preparation and submission to health authorities (HA) in the African region for new market authorization.
Maintain the existing authorizations, file the post approval changes, annual retentions, and renewals.
Prepare the market authorization internal data trackers and other supporting documents.
Collate and update the company databases for national registrations requirements.
Manage the pharmacovigilance and post-market surveillance activities as the deputy Local Safety Officer /QPPV Coordinate quality audits and implementation of CAPAs in line with audit findings.
Serve as a primary Regulatory Affairs contact involved with clinical/scientific information exchanges.
Active participation in developing tools and resources for medical affairs team use to encourage consistency, transparency, and appropriate communication for both internal and external partnerships.
Provides medical, scientific and technical review and opinion as requested internally.
Prepare/review the company marketing and promotional materials.
Seek approval of marketing and promotional materials/activities from the health authorities.
May lead and/or coordinate special projects as it relates to building scientific & medical competencies within the organization, such as: internal training of sales & marketing.
Proactively manage and mitigate issues through engagements with relevant stakeholders.
Represent the company in the industry associations committees.
Act as the superintendent pharmacist for the company's warehouse.
Professional Competencies Bachelor's degree in pharmacy from a university recognized by the Pharmacy and Poisons Board (PPB).
3-5 years experience in a similar role Hold a valid registration with PPB and practicing license.
Ready to work in a culturally diverse team.
Ability to work independently and as part of a team.
Skills: communication, negotiation, teamwork, and attention to details.
Experience in Regulatory affairs/Pharmacovigilance is an added advantage.
