 To handle all the statutory requirements pursuant to the office of the RA Manager. To undertake all governmental regulatory affairs including timely registration of products, obtaining of the relevant licenses, and maintaining a cordial working relationship with Ministries of Medical Services and Public Health; and other governmental and professional bodies. Undertake the preparation, submission and follow up of product registration and / or re-registration documents with both the local and foreign statutory bodies.  Ensure proper management and safe keeping of records in compliance with local legal and regulatory guidelines.  Responsible for trademark registrations with concerned authorities (local and export regions) for DAWA products as requested by sales & marketing department. Giving technical support to Sales and Marketing with regard to advertisements and other promotional materials for products. Review promotional material to ensure compliance with current legislation. To coordinate all new product development work, including participating in the generation and approval of product literature and packaging material artworks. General company representation as regards regulatory affairs as assigned by the Chief Operations Officer or the Directors.  To participate in relevant committees as may be assigned from time to time.  Participate in both short and long term planning of Company operations. Update relevant personnel on any new rules or circulars from various organizations or DRAs.  Ensure timely registration of product trademarks as requested by sales & marketing department. Ensure cleanliness in the work station. Ensure timely retention, renewal of product and company licenses with various DRAs. Ensure products released to the market have relevant legal documents eg; Permits, product licenses etc. To undertake any other duties that may be lawfully assigned from time to time.

>Preparation of Registration dossiers of pharmaceutical products being manufactured by the company for submission in Kenya & other countries.>Making sure Good Manufacturing Practises are observed.>Also working hand in hand with Quality Control Department / Product Development Department. Co-ordinating with Drug regulatory authorities on various activities as concerns pharmaceutical product licensing.>Drafting artworks for unit boxes, labels & literature inserts for various pharmaceutical products.>Computerized record keeping of: - Certificates of analysis, Registration dossiers, Manufactured / expired products, Stability study reports.>Launching / submission of the newly prepared registration dossiers to the pharmacy & poisons board and other drug regulatory authorities for different countries for example Uganda, Tanzania, Burundi, Congo, Zambia, Malawi, Ethiopia, Botswana and many others.>Responding to queries or requests by experts from different drug regulatory authorities in Kenya & other countries.>Cross-checking dossiers prepared / work-done by RA officers in the department / documents from other departments. Assisting in work-plan, assigning and supervising work-done by RA officers.>Regular update to various departmental heads on the registration status of different products / any new regulations from various drug regulatory authorities.

>Preparation of Registration dossiers of pharmaceutical products being manufactured by the company for submission in Kenya & other countries.>Making sure Good Manufacturing Practises are observed.>Also working hand in hand with Quality Control Department / Product Development Department. Co-ordinating with Drug regulatory authorities on various activities as concerns pharmaceutical product licensing.>Drafting artworks for unit boxes, labels & literature inserts for various pharmaceutical products.>Computerized record keeping of: - Certificates of analysis, Registration dossiers, Manufactured / expired products, Stability study reports.>Launching / submission of the newly prepared registration dossiers to the pharmacy & poisons board and other drug regulatory authorities for different countries for example Uganda, Tanzania, Burundi, Congo, Zambia, Malawi, Ethiopia, Botswana and many others.>Responding to queries or requests by experts from different drug regulatory authorities in Kenya & other countries.>Cross-checking dossiers prepared / work-done by RA officers in the department / documents from other departments. Assisting in work-plan, assigning and supervising work-done by RA officers.>Regular update to various departmental heads on the registration status of different products / any new regulations from various drug regulatory authorities.