Performance and GHU Coordinator AFRICA Zone
- Responsible for Transversal activities that support Regulatory Africa Zone Organization.
- Point of contact for GRA performance, quality, operations, and transversal activities to assure Africa Zones are well trained and equipped to perform their activities and deliver commitments to Business Units and external stakeholders.
- Main interface with the RA team of the distributor between the distributor and Global GHU team
- Responsible to interact with the distributor to collect any new regulatory publications, requirements and ensure data base update.
- Responsible to monitor with the distributor the timely submission and approval of the dossiers.
- Responsible for transversal activities that support Regulatory GHU Zone Organization.
- Responsible to interact with all the appropriate stakeholders to ensure compliance of the GHU products and timely update of the Sanofi data base according to regulatory requirements and Sanofi policies.
Regulatory Transversal Project Lead AFRICA Zone will be responsible:
- Ensure adherence to applicable procedures and policies in relevant Regulatory Affairs Function in Africa check of local legislation and regulatory base, internal departments SOPs in cooperation with RA Head.
- Plan and control country Regulatory Affairs functions SOPs: monitor, keep all the internal base up-dated; ensure all RA SOPs are followed by the RA team, implementation of New SOPs.
- Veeva super Users: support Africa team to be data ready, developing job aid and training.
- Plai GRA super users
- Part of international transversal network
- Manage activities such as shortages, DHPC, B/R reevaluation, etc across Africa.
- Survey coordination across Africa to ensure answer timely manner.
- Train/coach Regulatory Associates regarding all performance activities: KPI, audit preparation, Renewal plan, discontinuation, veeva QC, monitor the planned approval date etc…
- Coordination of the dormant license within Africa /Follow up POP execution and RAP execution with supply chain
- Responsible for monitoring quality topics at country level (trainings, local QDs, CAPAs, JD)
- Supports Africa Zone Head in preparing and reviewing KPI and management reports
Qualifications/Education & work experience
- Education: Physician, Pharmacist, Chemist, Biologist or Business School
- Related Experience: Minimum of 5 years experiences in Regulatory Affairs
- Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams.
- Excel expert
- Strong Digital mindset
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.