Senior Regulatory Associate at RB

PURPOSE:

• To register health products in the South African and ensure compliance of those products under the regulations.
• To implement changes and effect up-dates, compile and maintain regulatory documentation and interpret changes in the regulatory environment.

PRINCIPAL ACCOUNTABILITIES:

• Create and amend registration dossiers as necessary for submission to the regulatory authorities in the South Africa, approved by Regulatory Affairs Manager.
• Monitor, collect and interpret regulatory issues and trends that will impact our RB products, policies and procedures in the South Africa.
• Interface with government agencies and industry associations in South Africa to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production for RB products.
• Advise Global Category Development, local R&D Operations and commercial on regulatory requirements and regulatory impact during the early phases of the NPD process for projects intended for launch in South Africa.
• Provide regulatory and product expertise in the development and clearance of advertising and label copy for existing and new products in South Africa markets.
• Ensure that updated and compliant Material and Product Safety Data Sheets (PSDS) exist for all products, under direction of Regulatory Affairs Manager.
• Compile and maintain a database of the regulatory status for all health products in South Africa, including those projects still in the process of regulatory approval.
• Ensure the required dossier updates are executed for South Africa health products at appropriate, regular intervals, in line with regulatory and internal standards

QUALIFICATIONS & EXPERIENCE:

• B Pharm or B Sc or equivalent
• Regulatory experience is a must (Minimum of 3 years)

SKILLS & PERSONAL ATTRIBUTES:

• Bias for action, capability to define, evaluate and take risks
• Commercial understanding of corporate and operational business imperatives
• Appetite for exploring new and previously uncharted territories
• Openness to change and ability to think out of the box
• Understanding of commercial/marketing imperatives
• Experience and ability to manage complex and multifunctional projects in ways that optimise the cost, quality and speed of delivery contributing to the flawless execution of RB projects