Job Purpose:
To implement regulatory strategies to deliver timely submissions and approvals of key business assets. Maintain regulatory and quality compliance by alignment with internal company processes and procedures. Drive positive regulatory change in SSA through networking and influencing.
Essential Job Responsibilities
Regulatory
Implement regulatory strategic programs to drive speedy marketing authorizations for Ferring pharmaceutical products, including NCEs and line extensions/new indications, in alignment with market commercial objectives/priorities in addition to registration maintenance activities
Active involvement with regional project teams to improve internal processes.
Support training and education programs with local regulatory contacts/NSM (National sales managers), by organizing and chairing regional regulatory Meetings, to ensure understanding and compliance of company regulatory processes, including timely management of product updates.
Challenge unfavorable pharmaceutical legislation. Network and establish influential relationships with national and/or international governments and trade associations, to achieve advantage for Ferring and the industry by helping to shape the regulatory environment in the SSA Area. This includes being involved in the Africa Regulatory Network (ARN), which comprises of regulatory managers from research based pharmaceutical companies.
coordinate and Follow up the SSA regulatory expenses and budget with LOC’s (local Operating company)/META (Middle East Africa and Turkey)
Maintain an up to date SSA data base, with all regulatory guidelines, submission/GMP fees, approval timelines
Quality and others
Coordinate with META, to implement quality processes to support the business activities, and be aligned with corporate (QMS) and local market policies.
Coordinate all PV activities
Candidate basic requirements and Qualifications:
A scientific background – degree and or higher degree in Medical/pharmaceutical sciences
Experience and understanding of regulatory processes in the developed and developing world (Kenya, and some other SSA countries).
Good understanding of technical and manufacturing issues
Good commercial understanding and appreciation.
Achievement, results driven
proven Communication, and negotiation Skills
External Knowledge – products, therapy, environment, DRA
Must be prepared to travel within territories in SSA.
The incumbent should at least have 2 years’ experience of Research based Pharma Industry in Kenya or/and other SSA countries.
Must be fluent in English, and Swahili. Good knowledge of French will be appreciated.
