NFT Consult Officer Regulatory Affairs Jobs in Kenya
Job Summary
The Officer Regulatory Affairs will support the company in shaping regulatory strategy and ensuring medicines are approved, compliant, and sustainably maintained in the market.
The role serves as a bridge between the company and health authorities by translating regulatory requirements into practical actions throughout the product lifecycle, securing and maintaining regulatory approvals, and ensuring ongoing compliance with local, regional, and global regulatory requirements.
Key Responsibilities
Manage product lifecycle activities including preparation and submission of marketing authorization applications, responses to regulatory queries, regulatory negotiations, post-approval variations, renewals, and maintenance of product licenses.
Participate in the development of regulatory strategies aligned with business objectives and scientific goals.
Advise the company and partners on regulatory pathway optimization to accelerate product approvals and market entry.
Ensure products comply with local and international regulatory requirements in all target markets.
Gather, collate, and critically evaluate scientific and technical information to support regulatory submissions.
Develop and implement response strategies for regulatory queries and requests for additional information.
Manage regulatory timelines, milestones, and commitments while coordinating input from Research & Development, Clinical, Quality, and Manufacturing teams.
Maintain productive relationships with regulatory authorities and external partners.
Review and approve product artworks, packaging materials, labels, and promotional content to ensure regulatory compliance.
Monitor changes in pharmaceutical regulations and provide regulatory intelligence and
impact assessments to internal stakeholders.
Maintain accurate records, documentation, and tracking of regulatory activities in accordance with the company's Quality Management System.
Participate in and advise on Quality Management System reviews, including Standard Operating Procedures (SOPs) and policy updates.
Perform any other duties assigned by management.
Qualifications
Education
Bachelor of Science Degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related field.
Experience
Minimum of 3 years' hands-on experience in Regulatory Affairs.
Skills and Competencies
Familiarity with Good Manufacturing Practice (GMP) requirements.
Strong understanding of Common Technical Document (CTD) formats and local/international health products regulatory guidelines.
Excellent analytical, organizational, and problem-solving skills.
High attention to detail and accuracy.
Strong report-writing and document-review skills.
Effective communication, cross-functional collaboration, and training capabilities.
How to apply
For more information and job application details, see; NFT Consult Officer Regulatory Affairs Jobs in Kenya
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