Job Description

Qualifications & Experience
Bachelorxe2x80x99s Degree in Pharmacy
Registered with the South African Pharmacy Council
1-2 yearsxe2x80x99 experience in Regulatory Affairs
Experience in orthodox, human medicines is an advantage
Demonstrable experience across the product development, commercialization, and life-cycle maintenance.
Sound project management capabilities
Proven ability to consistently deliver to quality, time and cost standards
Knowledge of new and emerging Acts, Regulations and Guidelines pertaining to the pharmaceutical industry.
Experience in use of CTD software builder and compilation of eCTD application will be an advantage such as docuBridgeDuties
Ensure timeous initiation and management of the registration process for new product submissions
Ensure approval of registration applications of all medicines with the relevant authorities
Completes specific pre-registration activities including receipt, screening, compilation and timeous submission of dossier/s Regulatory Authority
Ensures that all assigned dossiers are submitted timeously to relevant health authorities and are followed up on regularly in order to enable registrations
Ensures that required standards, protocols and processes around obtaining dossiers and gathering supporting data from suppliers are followed after signing of appropriate agreements
Ensure the maintenance/ update of registrations in accordance with the relevant legislation, regulations and guidelines
Receives, prepares and submits all applicable updates, variations, resolutions and any other correspondence required by the Regulatory Authority
Completes dossier audits of Registered Products for the assigned products
Conducts dossier due-diligences, post-registration variations for all applicable Regulatory Authorities in compliance with the latest regulatory guidelines and applicable Regulations within the specified time-lines in order to support the business and strategic company
objectives
Establish and maintain effective relationships with Regulatory Authorities
Manages relationships with the Regulatory Authorities to ensure more effective streamlining of the companyxe2x80x99s applications when required
Building sustainable relationships with internal and external stakeholders to achieve regulatory goals
Effectively managing, auditing and implementation of Regulatory systems
Prepare, review and adhere to Standard Operating Procedures (SOPxe2x80x99s) and local Regulatory Guidelines
Ensure alignment of personal and company valuesCore Competencies
Attention to detail
Knowledge of the Regulatory requirements for medical products in South Africa and other applicable territories.
Project management skills
Leadership skills
Ability to prioritise and work to tight deadlines
Systems approach
Cross Functional skills: Ability to network, liaise and negotiate with others
Ability to set standard and objectives and monitor progress
Problem solving and decision-making skills
Sound project management capabilities

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