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Regulatory Compliance Pharmacist Manager
Our client, a leading company in pharmaceutical and consumer health product distribution, is recruiting a Regulatory Compliance Pharmacist Manager to oversee all regulatory affairs and compliance activities in Uganda.
Job Context
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. This role requires an experienced pharmacist with in-depth knowledge of the Ugandan pharmaceutical regulatory framework and the ability to drive regulatory initiatives in 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 licenses for pharmaceutical and consumer health products with the National Drug Authority (NDA) and other relevant regulatory bodies.
- Ensure ongoing compliance with all applicable pharmaceutical, health, 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 up-to-date regulatory records, licenses, permits, and compliance documentation.
- Collaborate with Quality Assurance, Supply Chain, Commercial, and Medical teams to ensure regulatory compliance across operations.
- Establish 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 as applicable.
Candidate Profile
Qualifications and 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 of experience in regulatory affairs or regulatory compliance within the pharmaceutical industry.
- Demonstrated experience in 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.
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