Regulatory Affairs and Compliance Officer - Dar Es Salaam

Job Summary:
Encore Medics Ltd, a leading supplier of medical and analytical equipment, is seeking a skilled and experienced Regulatory Affairs and Compliance Officer to join our dynamic team. As a Regulatory Affairs and Compliance Officer, you will play a pivotal role in ensuring adherence to regulatory standards and compliance with quality assurance systems. Key responsibilities include overseeing product pre-registration, registration, and post-registration processes, providing effective and efficient quality assurance systems support to Encore Medics Ltd, including supporting the implementation and maintenance of the quality management system, and performing the day-to-day work to meet the compliance standards of the QMS and the local Regulator as applicable to global and local standards.
 
Roles and Responsibilities:
Pre-registration:
Dossier review

• Review and evaluate documentation before submission of dossier to the regulatory Authority (TMDA/TBS/GLCA) for registration.
• Communicate with the applicant/manufacturer on the requirements/deficiency of the dossier before submission of the application for registration of the products.
• Compile dossier after submission of information from applicant/manufacturer and approve submission of dossier for application of registration of product.

Registration Process

• Cooperate with the company finance department to ensure that all fees relating to drug registration are payable to the Authorities.
• Submit dossier, samples, and other requirements for application of product registration.
• Submit GMP documents, i.e., SMF, to the Authority for the site audit and coordinate with the Authority for the audit plans.
• Make a close follow-up on the application of registration of the product and facilitate the registration process by responding to queries addressed on time.
• Collect and confirm the registration certificate granted after registration approval.

Importation of Product

• Oversee the importation process of the product by applying for a permit for importation of the product (TMDA, TBS, GCLA online application system).
• Respond to querries that may arrise during customs clearance of the products.
• Inspect goods upon receiving to ensure they meet quality aspects and are in compliant with local regulatory requirements.
• Monitor storage of products under respective storage conditions at the premises.

Post RegistrationPost-marketing surveillance and Pharmacovigilance

• Take measures by reporting to TMDA on any issue relating to counterfeit drugs and substandard drugs identified on the market.
• Collect information relating to adverse drug reactions and report to TMDA.
• Coordinate the recall process of any product complaints from customers and take necessary measures.

 
Post Approval Regulatory Issues

• Apply for post-approval regulatory issues such as variation/alteration, promotional materials approval, and renewal of the registered product.
• Coordinate the payment of the annual retention fees for the principal companies.
• Renew application of product registered after expiration of registration time.
• Apply for any variation as per company and market interest.
• Apply for the approval of the promotional material.

 
Destruction Process

• Coordinate the destruction process for expired/damaged/recalled products.

 
Inspection of Goods

• Inspect goods upon receiving to ensure they meet quality aspects and our specifications.

 
Quality Systems (in all technical operations):

• Ensure that all SOPs are in place, in use, and updated.
• Support Encore Medics to ensure that all internal procedures and systems in use are compliant with QMS and local regulatory requirements, including but not limited to good storage and distribution practices (GSDP).

 
Key Performance Indicators:

• New product registrations
• Implementation of ISO standards
• SOP training and adherence
• Timely registration and application of import permits
• Timely report submission
• Timely addressing any issue related to product quality.