Coordinator of regulatory affairs

Descripción general

Pharmaceutical company requires person to the post of coordinator of regulatory affairs, the requirements are as follows
• Bachelor’s degree in pharmacy or life sciences
• Comprehensive knowledge of English (verbal and written).
• Minimum two years of experience or more in pharmaceutical regulatory affairs.
• Experience with registration of New Drugs and Generic Drugs in Colombia and in the region.
• Excellent knowledge of regulatory requirements of INVIMA and countries in the region
(e.g. Ecuador (ARCSA), Peru (DIGEMID) and Mexico (COFEPRIS).
• Ability to work accurately in an autonomous manner and manage his/her time.

are as follows funciones
• Maintenance and renewal of current product registrations in Colombia.
• Filing and obtaining approval of amendments of current product registrations in Colombia.
• Filing and obtaining INVIMA approval of new product applications in Colombia.
• Coordinating the registration of products in countries in the Latin American region
(including Ecuador, Peru, Bolivia, Paraguay, Uruguay and Mexico).
• Help develop and review product label texts.
• Submit variations of registered products.
• Maintain current registrations.
• Format and regularly update Registration Dossiers of products that are manufactured in Colombia for the domestic market and export market.
• Prepare applications for submission as per local official guidelines (Colombia and other countries in the region).
• Submit new registration applications (new chemical entities and generic drugs).
• Inform head office when relevant new regulations are introduced.
• Ensure accurate communication between Head Quarters and the local manufacturer in Colombia, to comply with all issues such as documentation, artwork, stability studies, renewals, etc.
• Responsible for receiving, analysing and responding to queries from regulatory authorities

Requisitos para postularse

Pharmaceutical company requires person to the post of coordinator of regulatory affairs, the requirements are as follows
• Bachelor’s degree in pharmacy or life sciences
• Comprehensive knowledge of English (verbal and written).
• Minimum two years of experience or more in pharmaceutical regulatory affairs.
• Experience with registration of New Drugs and Generic Drugs in Colombia and in the region.
• Excellent knowledge of regulatory requirements of INVIMA and countries in the region
(e.g. Ecuador (ARCSA), Peru (DIGEMID) and Mexico (COFEPRIS).
• Ability to work accurately in an autonomous manner and manage his/her time.