Regulatory Affairs Manager

Overview

Zenufa Laboratories Ltd, a prominent pharmaceutical manufacturer based in Dar es Salaam, Tanzania, is seeking a Regulatory Affairs Manager to oversee its regulatory strategies across Tanzania and the East African Community (EAC) region. This leadership role is pivotal in ensuring product compliance with all regulatory standards and upholding the company's market leadership.

Key Responsibilities

• Oversee and lead all regulatory submissions to bodies such as the Tanzania Medicines and Medical Devices Authority (TMDA), EAC, and other regional regulatory agencies.
• Formulate, execute, and update regulatory strategies for the introduction of new pharmaceutical products.
• Manage the preparation, maintenance, and timely renewal of product registration dossiers.
• Ensure adherence to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and relevant local pharmaceutical laws and regulations.
• Act as a liaison between Zenufa Laboratories and regulatory authorities including TMDA and international agencies.
• Lead and supervise a team comprising four regulatory affairs specialists.
• Continuously monitor regulatory developments and provide guidance to company management on regulatory impacts.

Qualifications and Experience

• Possession of a Bachelor of Pharmacy (BPharm) degree is mandatory; a Master’s degree in Regulatory Science or a related discipline is preferred.
• Registration with the Pharmacy Council is required.
• Minimum of seven years of extensive experience in pharmaceutical regulatory affairs.
• In-depth understanding of TMDA, EAC regulations, and WHO prequalification processes.
• Proficient in the preparation of Common Technical Document (CTD) and electronic CTD (eCTD) dossiers.
• Demonstrated strong project management abilities and leadership skills.

Compensation and Benefits

• Attractive monthly salary ranging from TZS 5,000,000 to 8,000,000.
• Eligibility for performance-based bonuses.
• Provision of a company vehicle for official use.
• Comprehensive family health insurance coverage.
• Allocated budget for professional development and training.
• Opportunities for international travel as part of job responsibilities.

About Zenufa Laboratories

Zenufa Laboratories is a leading pharmaceutical company in Tanzania, producing a broad range of over 200 medicinal products including tablets, capsules, syrups, and injectable formulations for both local and regional markets.