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Global Regulatory Manager (M/F) - Kenya - Healthcare
Experience with healthcare and/or chemical international companies
Experience with regional/global positions
À propos de notre client
Our client is a global and family-owned company of the healthcare industry. As part of a strong development in Africa, we are looking to recruit a Global Regulatory Affairs Manager (M/F) to be based in Kenya or elsewhere in Africa.
Description du poste
Based in Nairobi or in other countries of Africa where the group has its activities, you report to the Group Sales Director region and manage product regulatory activities in accordance with the worldwide business unit strategies.
In line with this role, you will be expected to fulfill the following assignments:
- Managing the global regulatory department to ensure objectives are aligned with the organizational goals and fulfilled as per the defined timelines,
- Submitting the annual regulatory budget for approval and managing its implementation,
- Ensuring registration of products of Public Health and Food Security globally and as strategized by the Business Units,
- Identifying national and regional registration guidelines, dossier contents, data requirements, timelines and costs to complete the registration activities,
- Working in close co-ordination with Sales and Market Access functional for entry barriers, review and finalization of products to ensure high quality regulatory documents and effective data presentation for product registrations as per regulatory guidelines,
- Coordinating with internal/external laboratories and institutes for any necessary testing and trials,
- Ensuring product labelling claims are correct and up to date and timely renewal of product registrations,
- Maintaining efficient relationship with countries' Regulatory Authorities and responding to their queries using scientific methodical approach,
- Preparing products safety data sheets (SDS) as per GHS standard and new product risk assessment reports as per the latest World Health Organization (WHO),
- Updating the internal central regulatory database for updated information access to sales teams,
- Updating the Group when it comes to keeping abreast of relevant regulatory developments and regulations.
You have a Master's degree in chemistry, pharmaceutical, toxicology or related sciences with a minimum of 5 years' experience in a multi-regional or global role including Africa with international companies of the healthcare or chemical industries. Knowledge of pharmaceutical and/or chemical regulations and related regulation bodies is essential for this role. Hands-on, multi-tasking and self-driven, you can naturally work independently in a stand-alone position.
Attractive consultancy package