Senior Manager - Regulatory Affairs EE (Midrand)

SUMMARY:
Our client is looking for a Senior Manager within Regulatory Affairs to join their team within the Pharma Sector in their Midrand Office EE Candidates only

POSITION INFO:

Job Specification

Manages submissions to different Health Authorities within the Regulatory Affairs function

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

Provides regulatory Intelligence

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 

New Business Development Implementation

Supports and enables delivery of Regulatory Affairs, Pharmacists/Scientists

Develops and manages stakeholder relationships

Lead and develop the regulatory affairs team

Minimum Requirements

EE candidates

Senior Manager - Regulatory Affairs 

5-10 years’ experience in regulatory affairs covering all areas of the function

2-3 years’ experience in managing others

Proven skills in Business acumen

People Management experience

Negotiation and influencing skills and a collaborative approach

Kindly note that by submitting your application for this career opportunity you agree that Guardian Recruiting may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business.

Please note that only shortlisted candidates will be contacted.

Should you not have heard back within a two-week period, please assume that your application was unsuccessful.

All job postings are in accordance with our Client''s BEE requirements

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