Our client, an importer, exporter, and distributor of pharmaceutical products, is seeking to recruit a highly experienced and professional Regulatory Affairs & Training Manager to lead regulatory compliance activities and drive capability development across the organization.

The ideal candidate will be responsible for managing regulatory submissions, product registrations, compliance requirements, and maintaining strong relationships with regulatory authorities. The role will also oversee the design and implementation of training programs to strengthen the knowledge and performance of commercial and technical teams.

The successful candidate should possess strong leadership skills, executive maturity, and a deep understanding of Kenyan pharmaceutical regulatory requirements.

Key Responsibilities

Regulatory Affairs

• Manage product registrations, renewals, variations, and regulatory submissions in compliance with applicable regulations.
• Ensure all company products and operations comply with Kenyan pharmaceutical and healthcare regulatory requirements.
• Liaise and maintain strong working relationships with regulatory bodies and relevant stakeholders.
• Monitor changes in regulatory legislation and provide guidance to management and internal teams on compliance requirements.
• Coordinate preparation and submission of regulatory documentation and ensure timely approvals.
• Support audits, inspections, and compliance reviews as required.
• Work closely with cross-functional teams including commercial, quality assurance, supply chain, and senior leadership.

Training & Capability Development

• Develop and implement training programs for commercial and technical teams.
• Identify capability gaps and provide coaching and development support to staff.
• Facilitate regulatory and product knowledge training sessions.
• Evaluate training effectiveness and recommend continuous improvement initiatives.
• Support onboarding and continuous professional development initiatives across departments.

Qualifications & Experience

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
• Minimum of 7 years’ relevant experience in regulatory affairs, preferably within the pharmaceutical or healthcare industry.
• Proven experience in regulatory submissions, product registrations, compliance management, and stakeholder engagement with regulatory authorities.
• Demonstrated experience in training, coaching, and capability development.
• Membership in relevant professional bodies is an added advantage.

Key Competencies

• Strong leadership and people management skills.
• High level of professionalism and executive maturity.
• Excellent communication, presentation, and interpersonal skills.
• Strong understanding of Kenyan pharmaceutical regulatory requirements.
• Ability to work cross-functionally with multiple departments and leadership teams.
• Strong organizational, analytical, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines effectively.

• Manage product registrations, renewals, variations, and regulatory submissions in compliance with applicable regulations.
• Ensure all company products and operations comply with Kenyan pharmaceutical and healthcare regulatory requirements.
• Liaise and maintain strong working relationships with regulatory bodies and relevant stakeholders.
• Monitor changes in regulatory legislation and provide guidance to management and internal teams on compliance requirements.
• Coordinate preparation and submission of regulatory documentation and ensure timely approvals.
• Support audits, inspections, and compliance reviews as required.
• Work closely with cross-functional teams including commercial, quality assurance, supply chain, and senior leadership.
• Develop and implement training programs for commercial and technical teams.
• Identify capability gaps and provide coaching and development support to staff.
• Facilitate regulatory and product knowledge training sessions.
• Evaluate training effectiveness and recommend continuous improvement initiatives.
• Support onboarding and continuous professional development initiatives across departments.

• Strong leadership and people management skills.
• High level of professionalism and executive maturity.
• Excellent communication, presentation, and interpersonal skills.
• Strong understanding of Kenyan pharmaceutical regulatory requirements.
• Ability to work cross-functionally with multiple departments and leadership teams.
• Strong organizational, analytical, and problem-solving skills.
• Ability to manage multiple priorities and meet deadlines effectively.

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field.
• Minimum of 7 years’ relevant experience in regulatory affairs, preferably within the pharmaceutical or healthcare industry.
• Proven experience in regulatory submissions, product registrations, compliance management, and stakeholder engagement with regulatory authorities.
• Demonstrated experience in training, coaching, and capability development.
• Membership in relevant professional bodies is an added advantage.