Summary

The Regulatory Affairs Expert will be responsible for ensuring that all nutraceutical products comply with local regulatory requirements. The role involves managing product registrations, handling regulatory submissions, and liaising with relevant authorities to facilitate smooth market entry and compliance.

Responsibilities

 

• Manage end-to-end product registration processes with regulatory authorities (e.g., TMDA, TBS)
• Prepare, review, and submit regulatory dossiers in compliance with local guidelines
• Ensure product labelling compliance in line with applicable regulations
• Coordinate and obtain import permits and other necessary approvals for product entry
• Act as the primary point of contact with regulatory bodies and ensure timely communication
• Monitor changes in local regulatory requirements and advise internal stakeholders accordingly
• Maintain accurate and up-to-date regulatory documentation and records
• Support product launches by ensuring all regulatory approvals are in place
• Work closely with internal teams (e.g., quality, supply chain, and commercial) to ensure compliance
• Assist in audits and inspections related to regulatory compliance

 

Education and Qualifications

 

• Bachelor’s degree in Pharmacy, Regulatory Affairs, Life Sciences, or a related field
• Strong attention to detail and ability to manage multiple submissions simultaneously
• Excellent communication and stakeholder management skills

 

Requirements

• Minimum of 5 years’ experience in Regulatory Affairs, specifically within the nutraceutical sector
• Proven experience with TMDA and TBS product registrations
• Strong knowledge of dossier preparation and submission processes
• Solid understanding of labelling regulations and compliance requirements
• Experience handling import permits and local regulatory procedures

Characteristics

 

• Strong knowledge of local regulatory frameworks in Tanzania
• Analytical and detail-oriented approach
• Ability to work independently and meet tight deadlines
• High level of integrity and professionalism
• Strong organizational and documentation skills

 

Reporting To

Manager – T&D and Corporate Communications