Performance and GHU Coordinator AFRICA Zone

Job Description

Performance and GHU Coordinator AFRICA Zone will report to Country Regulatory Head Morocco Tunisia LybiaOverall Responsibilities

• 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
• 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, Annexe F, audit preparation, Renewal plan, discontinuation etc
• Coordination of the dormant license within Africa

Responsibilities include:

• 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
• Demonstrated ability to independently lead teams and implement regulatory strategies.
• Excellent understanding of the pharmaceutical industry, drug development environment, and company processes and objectives.
• Expert knowledge of AFRICA pharmaceutical regulations and requirements, Health related regulations (i.e. ICH, FDA, EU, WHO, ANSM, MHRA, Emergent Markets, etc.).
• Ability to evaluate the impact of the regulations on drug development and the regulatory maintenance of Marketing Authorizations.
• Comprehensive knowledge and operational expertise of the international regulations.
• Ability to communicate effectively and efficiently with other functional departments in the business.
• Good organizational skills and ability to manage a large workload under pressure and to cope with tight deadlines. Ability to foresee and respond to potential problems and opportunities.
• Ability to quickly gain required therapeutic / product knowledge.
• Ability to work with multifunctional and multicultural teams.
• Fluent English.
• Awareness and adherence to company internal SOPs & compliance standards.
• Promptness in respond to authoritys requirements and prompt in deliverables.
• Analytical skills.
• Problem solving skills.
• An understanding and appreciation of relevant legal, scientific and manufacturing area.

Experiences :

• Education: Physician, Pharmacist, Chemist, Biologist.
• Related Experience: Minimum of 5 years experiences in pharmaceutical development, Regulatory Affairs, Clinical, Pharmacovigilance or Quality Assurance.
• Project management experience in the pharmaceutical industry or in a regulatory environment. Recognized expert in managing matrix teams.

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.

Keyskills :