Laboratory & Allied Regulatory Affairs Officer and Deputy Head of Regulatory Affairs Jobs

76

Applications are invited from qualified candidates to fill the following positions.

Vacancy: Regulatory Affairs Officer
The successful applicant should meet the following qualifications:
• Must hold a minimum of Diploma in Pharmacy or its equivalent.
• Specialized knowledge- should be computer literate.
• At least 2 years work experience in the same position.
• Skills: Team player, good communicator, keen, creative & innovative.
• A person of unquestionable integrity.
Duties & Responsibilities
The successful candidate shall perform the following duties:
• Timely compilation of registration dossier for Kenya and other countries as per required format and guidelines.
• Liaising with RA Officer Assistant to get relevant data for dossier preparation from QC / QA/ production departments and contract (external) manufacturers.
• Maintaining progress reports for all RA operations for presentation at meetings and to the management.
• Screening/Review of registration dossiers from contract manufacturers before submission to PPB – Kenya.
• Information search from available sources for drug registration.
• Assist in responding to queries raised by various regulatory bodies on drug product registration.
• Keeping track with the ever changing legislation in all countries where the company wants to market their products.
• Proper record keeping of all Regulatory documents assigned in a manner that they are retrievable whenever required.
• Any other lawfully assigned duties from time to time within the RA department.
Vacancy: Deputy Head – Regulatory Affairs
The successful applicant should meet the following qualifications:
• Must hold a minimum of Diploma in Pharmacy or its equivalent.
• Skills: Strong verbal and written communication and presentation skills, excellent interpersonal skills and ability to work effectively and build relationships with cross-functional teams, Self-motivated and Result Oriented.
• At least 3 years work experience in regulatory Affairs department.
• A person of unquestionable integrity.
Key Competencies
The successful candidate shall perform the following duties:
• Assist the Head of Regulatory Affairs to ensure the smooth running of the RA department.
• Check all drug registration dossiers and ensure that they are prepared as required before submission.
• Ensure that all samples submitted for drug registration are as per requirements.
• Schedule and assign the dossiers to be prepared to RA officers.
• Give weekly updates on progress of drug registration as required by other departments.
• Follow up of product registration and / or re-registration documents with both the local and foreign drug regulatory authorities as required.
• Give technical assistance on dossier preparation to the RA officers as required.
• Ensure that there is an updated status on all registered products of the company and those that are under registration process.
• Timely response to all queries or items requested by various drug regulatory authorities.
• Submission / follow up on pre-registration analysis of samples submitted to WHO-prequalified laboratories.
• Follow up on trade mark registration as requested by sales & marketing department.
How to Apply
Applications addressed to the Human Resource Manager enclosed with a CV & indicating the position applied for can be send to HR office on or before 4.30 pm Friday October 30, 2015. NB: All CVs must have a coloured passport sized photograph
E-mail to: [email protected]

SHARE