The Role
Lead regulatory affairs and compliance in Uganda: manage product registrations, renewals, variations with the NDA, ensure GDP/GMP/pharmacovigilance compliance, coordinate inspections, oversee product release, maintain regulatory records, support cross-functional teams, mentor the regulatory team, and contribute to regional regulatory projects.
Summary Generated by Built In
Job Title: Regulatory Compliance Pharmacist Manager
Location: Kampala, Uganda
Employment Type: Full-Time
Industry: Pharmaceutical
Eligibility: This position is open to Ugandan nationals only.
Role Overview
Our client, a leading pharmaceutical and consumer healthcare distribution company, is seeking to recruit a Regulatory Compliance Pharmacist Manager to oversee all regulatory affairs and compliance activities in Uganda. The successful candidate will ensure that the organization's products, operations, and quality systems comply with all applicable regulatory requirements while supporting business growth through timely product registrations and regulatory approvals.
The role requires an experienced pharmacist with extensive knowledge of Uganda's pharmaceutical regulatory framework and the ability to lead regulatory initiatives across a dynamic business environment.
Key Responsibilities
• Lead the company's regulatory affairs and compliance function in Uganda.
• Manage the registration, renewal, variation, and maintenance of pharmaceutical and consumer healthcare product licenses with the National Drug Authority (NDA) and other relevant regulatory bodies.
• Ensure continuous compliance with all applicable pharmaceutical, healthcare, and consumer product regulations.
• Develop and implement regulatory strategies to support new product launches and market expansion.
• Review and approve regulatory documentation, submissions, and product dossiers.
• Coordinate regulatory inspections, audits, and responses to regulatory findings.
• Oversee product release processes to ensure compliance with regulatory and quality standards.
• Monitor changes in regulatory legislation and communicate their impact to the business.
• Maintain regulatory records, licenses, permits, and compliance documentation.
• Collaborate with Quality Assurance, Supply Chain, Commercial, and Medical teams to ensure regulatory compliance across business operations.
• Build and maintain strong relationships with regulatory authorities and external stakeholders.
• Provide regulatory guidance to internal teams and support cross-functional decision-making.
• Lead, mentor, and develop the Regulatory Affairs team to achieve departmental objectives.
• Support regional regulatory initiatives and contribute to multi-country regulatory projects where applicable.
Requirements
Qualifications & Experience
• Bachelor's Degree in Pharmacy (BPharm) or equivalent from a recognized institution.
• Registered Pharmacist with a valid practicing license in Uganda.
• Minimum of 8 years' experience in Regulatory Affairs or Regulatory Compliance within the pharmaceutical industry.
• Demonstrated experience managing pharmaceutical product registrations and regulatory submissions with the National Drug Authority (NDA).
• Previous experience leading a regulatory affairs or compliance team.
• Experience working in a regional or multi-country pharmaceutical environment is highly desirable.
• Strong understanding of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), pharmacovigilance, and pharmaceutical regulatory requirements.
• Proficiency in Microsoft Office applications and regulatory information management systems.
Key Competencies
• In-depth knowledge of Uganda's pharmaceutical regulatory framework.
• Strong leadership and people management skills.
• Excellent planning, organizational, and project management abilities.
• High level of integrity and attention to detail.
• Strong analytical and problem-solving skills.
• Excellent communication, negotiation, and stakeholder management skills.
• Ability to manage multiple regulatory projects simultaneously while meeting strict deadlines.
• Sound decision-making and risk management capabilities.
Preferred Experience
• Experience supporting regulatory compliance for pharmaceutical and consumer healthcare products.
• Exposure to regulatory requirements across multiple East African markets is an added advantage.
• Experience interacting with regional regulatory agencies and international regulatory standards.
Skills Required
- Bachelor's Degree in Pharmacy (BPharm) or equivalent
- Registered Pharmacist with a valid practicing license in Uganda
- Minimum of 8 years' experience in Regulatory Affairs or Regulatory Compliance within the pharmaceutical industry
- Demonstrated experience managing pharmaceutical product registrations and regulatory submissions with the National Drug Authority (NDA)
- Previous experience leading a regulatory affairs or compliance team
- Experience working in a regional or multi-country pharmaceutical environment
- Strong understanding of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP), and pharmacovigilance
- Proficiency in Microsoft Office applications and regulatory information management systems
- In-depth knowledge of Uganda's pharmaceutical regulatory framework
- Leadership and people management skills
- Planning, organizational, and project management abilities
- Ability to manage multiple regulatory projects and meet strict deadlines
- Experience supporting regulatory compliance for pharmaceutical and consumer healthcare products
- Exposure to regulatory requirements across multiple East African markets
- Experience interacting with regional regulatory agencies and international regulatory standards
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The Company
What We Do
We go the extra mile for your last mile – with specialized divisions to serve even the most diverse of industries. CDL is your premier regional carrier for complete delivery coverage – guaranteed.
