SENIOR MANAGER - Midrand Verfied

R 900k per annum Midrand, Gauteng Midrand, Gauteng more than 14 days ago 19-02-2020 12:30:23 PM
15-04-2020 12:30:23 PM
REPORTS TO:

Regulatory Affairs Director/ Regulatory Affairs Executive.

KEY ACCOUNTABILITIES

• Assists the Regulatory Affairs Department Managers/Executives and Director by providing: - Regulatory intelligence pertaining to the current regulatory landscape and potential impact for the team and wider business related to products variations and registration/ approvals for SA. - Up to date information on the different local and worldwide regulatory issues and specific regulatory requirements for different geographies where company is involved

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

ENSURE PRE-LAUNCH STAGE PRODUCT SUBMISSION AND REGISTRATION ACTIVITIES

• Provides direction and guidance to the Regulatory Affairs Pharmacists and Scientists for specific pre-registration activities and ensures that assigned workload and activity timelines are effectively set, managed and communicated. • Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to ensure first to market registrations. • Ensures that the Regulatory Affairs Pharmacists and Scientists follow the standards, protocols and processes around obtaining dossiers and gathering supporting data from IPD and 3rd party suppliers following signing of supply / purchase / financial agreements

EDUCATIONAL QUALIFICATIONS/ SKILLS AND KNOWLEDGE

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.

Please note: Should we not respond to your application within 7 days, consider your application unsuccessful.