Regulatory Affairs Manager

• Manages submissions to different Health Authorities within the Regulatory Affairs function by ensuring the targets are reached as committed during eachfinancial year.

• Manages registrations and engagement with the different Health Authorities to ensure targets are metw.r.t.registrations and launches.

• Manages every aspect of product Life-Cycle management within the Regulatory Affairs function by ensuring that the dossierssubmittedand registered are up to date with any changes or variationsin order toensure dossier compliance and maintenanceand minimize risk.Ensuresthat administration related to the Management of these processes are conducted according to departmental procedures for all products.

• Leads a group of RA Pharmacists/Scientistsdirectly in all aspects related toobjectivesand delivery thereof.

• Provides RA Intelligence to RA Executiveand RA Director on all projects and processes related tokeyobjectives

Key Accountabilities

• Provides regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and insight into impact to business and strategies to adapt.
• Ensures pre-launch stage product submission and registration activities
• Ensures dossier life cycle management registration activities by ensuring the following activities are conducted
• New Business Development Implementation
• Develops and manages stakeholder relationships
• Lead and develop the regulatoryaffairsteam

Employment Equity

Cipla is an Employment Equity employer and this position will be filled based on our Employment Equity Plan.