Regulatory Affairs Manager/pharmacist - Johannesburg Verfied

Salary Negotiable Johannesburg, Gauteng Johannesburg, Gauteng more than 14 days ago 11-09-2014 4:01:06 PM
09-10-2014 4:01:06 PM
An opportunity for an experienced and knowledgeable Regulatory Affairs Pharmacist is available within a managerial position.

Requirements:
B.Pharm
A minimum of 5 years' RA experience
Extensive Sub-Saharan exposure
Working knowledge of pharmacological and pharmaceutical principles
Knowledge of new regulations and laws

Responsibilities:
Providing regulatory reports pertaining to the current regulatory landscape and potential impacts for the team and wider business
Product submission and registration activities
Provide direction and guidance to the Regulatory Affairs Pharmacists for specific registration activities
Ensure that assigned workload and activity timelines are effectively set, managed and communicated
Ensure that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly
Ensure that the Regulatory Affairs Pharmacists follow the standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers following
Submission of Clinical Trial Authorisation applications and subsequent applications
Communication to Regulatory Affairs and Drug Safety & Public Health of any new or changed national regulatory