Regulatory Affairs Manager

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. E nsure s that administration related to the Management of these processes are conducted according to departmental procedures for all products.
• L ead s 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

Key Accountabilities

• Provides regulatory Intelligence to Cipla RA Managers/Executives/ RA Director and CEO. Provides 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 regulatory affairs team

Educational Qualifications

B Pharm degree or higher (post graduate)

Relevant Experience

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.

Employment Equity

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