Senior Manager – Regulatory Affairs

Senior Manager – Regulatory Affairs

Regulatory
Gauteng
Job Purpose
 
  • Manages submissions to different Health Authorities within the Regulatory Affairs function by ensuring the targets are reached as committed during each financial year.
  • Manages registrations and engagement with the different Health Authorities to ensure targets are met w.r.t. registrations and launches.
  • Manages every aspect of product Life-Cycle management within the Regulatory Affairs function by ensuring that the dossiers submitted and registered are up to date with any changes or variations in order to ensure dossier compliance and maintenance and minimize risk. Ensures that administration related to the Management of these processes are conducted according to departmental procedures for all products.
  • Leads a group of RA Pharmacists/Scientists directly in all aspects related to objectives and delivery thereof.
Provides RA Intelligence to RA Executive and RA Director on all projects and processes related to key objectives
 
REQUIREMENTS
 
B Pharm degree or higher (post graduate)
 
Min. 5-10 years’ experience in regulatory affairs covering all areas of the function.
 
At least 2-3 years’ experience in managing others. Proven skills in Business acumen, People Management experience, Negotiation and influencing skills and a collaborative approach.