Applications are invited from qualified candidates to fill the following positions.
Vacancy: Regulatory Affairs Officer
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.
The successful applicant should meet the following qualifications:
- Must hold a BSC degree or its equivalent.
- Specialized knowledge in regulatory affairs
- 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.
If you possess the above qualifications, please send your CV to firstname.lastname@example.org on or before close of business 2nd September 2016.
Suitable candidate should be willing to commence work ASAP.