HOUSEHOLD AND PHARMACEUTICAL INDUSTRY

PURPOSE:

• To register household and pharmaceutical products in the Southern African Region 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 amending registration dossiers as necessary for local and regional requirements for submission to the regulatory authorities in the Southern African Region, approved by Regulatory Affairs Manager.

•Monitor, collect and interpret regulatory issues and trends that will impact our products, policies and procedures in the Southern African Region.

•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, labeling and production for our products.

•Ensure compliance with company RSE policy, guidelines and procedures within the Middle East Africa region, and approved by Regulatory Affairs Manager.

•Advise Global Category Development and regional Scientific Services and business personnel on regulatory requirements and regulatory impact during the early phases of the NPD process for projects intended for launch in Southern African region, and approved by the Regulatory Affairs Manager.

•Organize internal audits of manufacturing sites and monitor audits performed by 3rd Parties, approved by Regulatory Affairs Manager, South Africa.

•Provide regulatory and product expertise in the development and clearance of advertising and label copy for existing and new products in South African markets. Maintain the filing of approved artwork and advertising copy.

•Participate with the Regional RS&E Manager in internal investigations into allegations of non compliance and coordinate the activities necessary to expeditiously resolve regulatory disputes.

•Ensure that updated and compliant Material and Product Safety Data Sheets (PSDS) exist for all products, under direction of RS&E Manager, MEA.

•Compile statutory safety reports, approved by RS&E Manager, MEA.

•Compile and maintain a database of the regulatory status for all regulated products in the MEA Region, including those projects still in the process of regulatory approval.

•Ensure the required dossier updates are effected for the Region at appropriate, regular intervals, in line with regulatory and internal standards.

•Ensure the alignment between manufacturing documentation and the latest approved regulatory documents.

•Establish and maintain a database for the payment of various regulatory/ statutory fees.

•Audit the availability of TEX/TDS documentation for all projects implemented in the Middle East Africa region by the SSG function according to company policy requirements and maintain a database of the status of these audits.

•Perform any specific tasks as required by Regulatory, Safety and Environmental Affairs Manager, MEA.


QUALIFICATIONS & EXPERIENCE:

• B Pharm, preferably with post-graduate qualifications.
• Regulatory experience is a must.

SKILLS REQUIRED:

• Strong written and verbal communication and interpersonal skills essential.
• Understanding of commercial/marketing imperatives.
• Legal requirements (environment, patents, Advertising Standards Authority, Metrology Act, Foods, Cosmetics and Disinfectants Act) - local & regional
• Regulatory experience is a recommendation
• Analytical skills a must and fully computer literate.

Email:ddgrib@gmail.com

Cell: 0825801507

Work: 0110211817 / 608