Drug Regulatory Head ,HRD in Healthcare - Kenya

To achieve registration of new products, line extensions and new indications and maintain existing registration dossiers by managing all regulatory matters in all spheres of activity (Registration, Production, Marketing).

To provide regulatory intelligence and manage the regulatory environment with internal and external scientific and marketing support for the East African Region – based in Kenya

Key Result Areas

• Regulatory submissions of new chemical entities, new indications and line extensions
• Maintenance of regulatory dossiers and licenses
• Input to regulatory strategies aligned with commercial and Regional objectives
• Organizational regulatory compliance
• Staff management and development
• Customer relations management – internal and external
• Successful stakeholder management eg Health Authorities within the various countries
• Budgeting and financial management of internal and external budgets
• Corporate governance

Desired Skills & Experience

Minimum Entry Criteria

• Doctorate of State/University Degree in Pharmacy or Life Sciences
• At least 5-7 years Regulatory Experience in Pharmaceuticals
• Currently in a Senior Regulatory role
• Based in Kenya
• Experience in distributor interactions
• Good spoken and written English
• Preference for development exposure of new drugs and clinical trial experience
• Preference for EU Regulatory exposure and awareness

 Experience

Thorough knowledge of regulatory processes, local legislation, regulatory requirements for registration and promotion of medicines, budgeting and finances, MS Office.

Behaviours

Ability to work under pressure, self motivated, attention to detail, customer focused, team player, proactive, assertive, initiative, diplomatic, sets clear direction and aligns team and others around objectives, drives superior results and has passion to succeed.

Skills

Planning & organizational, analytical, communication – verbal and written (internal & external), leadership, presentation, interpersonal, negotiation, coaching, team selection/ recruitment, insightful thinking, ability to drive and bring results.

Company Description

Strategic resourcing and HR consulting in the Pharmaceutical and Healthcare sectors. Specialising in Executive Search and Recruitment, including Commercial and Medical opportunities. Over 25 years experience with a strong network of clients and candidates.
email: carol@hrdh.co.za