Regulatory Affairs Pharmacist, Business Solutions – Diagnostics

Our client, a global leader in healthcare and diagnostics, is seeking a highly motivated Regulatory Affairs Specialist, Business Solutions – Diagnostics to support regulatory activities across East Africa.

Key Responsibilities

Regulatory Strategy & Market Access

• Develop and execute regulatory strategies for diagnostic products across East African markets.
• Monitor regulatory changes, legislation, and evolving market requirements.
• Support regulatory advocacy initiatives and engage with health authorities and industry stakeholders.
• Contribute to healthcare policy discussions and regulatory convergence initiatives.

Registration & Product Lifecycle Management

• Prepare, compile, and submit regulatory dossiers and registration applications.
• Manage registration approvals, renewals, variations, and product maintenance activities.
• Maintain accurate records of licenses, registrations, approvals, and expiry dates.
• Ensure ongoing compliance of products throughout their lifecycle.

Commercial & Business Support

• Provide regulatory support for tenders, technical evaluations, and health technology assessments.
• Support commercial teams, distributors, and business stakeholders on regulatory matters.
• Assist with product launch activities and market entry initiatives.
• Respond to regulatory enquiries from internal and external stakeholders.

Compliance, Quality & Vigilance

• Ensure compliance with applicable regulatory, vigilance, post-market surveillance, complaint handling, and recall requirements.
• Support Quality Management System (QMS) activities and regulatory SOP implementation.
• Collaborate with Quality and Safety teams on product-related incident reporting and field actions.
• Support regulatory inspections, audits, and authority interactions.

Stakeholder Engagement & Training

• Build strong relationships with regulatory authorities, ministries of health, distributors, and industry associations.
• Deliver regulatory guidance and training to associates, distributors, and business partners.
• Collaborate closely with cross-functional teams including Quality, Medical Affairs, Marketing, Supply Chain, and Commercial functions.

Minimum Requirements

Education

• Bachelor's Degree in Pharmacy, Life Sciences, Biomedical Sciences or related field.

Experience

• Minimum 3 years' Regulatory Affairs experience within Medical Devices, In Vitro Diagnostics (IVD), Diagnostics, Healthcare or Pharmaceutical industries.
• Proven experience managing regulatory submissions and registrations.
• Experience working with East African regulatory authorities and regulatory frameworks.
• Exposure to vigilance, post-market surveillance, and quality systems would be advantageous.

Knowledge & Skills

• Strong understanding of medical device and IVD regulatory frameworks across East Africa.
• Knowledge of product registration processes and lifecycle management.
• Understanding of quality management systems and vigilance requirements.
• Excellent communication and stakeholder management skills.
• Strong project management and organizational ability.
• Ability to manage multiple projects and deadlines simultaneously.
• High attention to detail and commitment to compliance.
• Proficiency in Microsoft Office applications and regulatory management systems.
• Fluent English communication skills.