Regulatory Affairs Specialist - Sandton - Procter & Gamble

Description

Job Responsibilities

As a Regulatory Affairs Associate Scientist at Procter & Gamble, you will be responsible for preparing and submitting registration dossiers and achieving registration for specific product brand categories under the Procter & Gamble Personal Healthcare portfolio and geographic territory, within agreed timelines.

Key Responsibilities:

• Defining requirements for local submission of registration dossiers for FSA, Sub-Saharan Africa, and North Africa countries
• Compiling, authoring, and publishing registration dossiers using electronic databases and repositories for FSA, Sub-Saharan Africa, and North Africa countries
• Submitting registration dossiers through third parties to achieve registration
• Updating and maintaining dossiers post-registration to ensure compliance with corporate and health authority legal requirements
• Retaining and renewing registration of products by defining accurate timelines
• Maintaining and updating regulatory files and records, including archiving relevant documentation in systems according to internal company standards
• Providing regulatory advice and guidance to the organization on potential risks and recommending compliant actions
• Reviewing and ensuring conformity of product artworks, promotional materials, and tools with marketing codes and legal requirements
• Liaising with health authorities in countries under responsibility to achieve and maintain registrations
• Developing relationships with regulatory and industry bodies to represent the organization's interests, gain information, and shape change
• Maintaining licenses for proper functioning of the company, such as GMP certificates and manufacturing licenses
• Providing regulatory advice on product development for international markets
• Staying up-to-date on dynamic regulatory, compliance, and statutory requirements in global, regional, and local environments to ensure organizational compliance
• Providing strategic input and support to the Regulatory Affairs Director for Middle East & Africa Cluster on local, regional, and global Regulatory Affairs objectives aligned with commercial objectives
• Updating and maintaining regulatory and tracking systems, as well as databases, with relevant current information and activity dates for all products as required

Qualifications and Experience

We are seeking a highly qualified and experienced Regulatory Affairs Associate Scientist to join our team. The ideal candidate will have a minimum of a bachelor's degree in health-related science, life science, pharmacy, or medical degree.

Key Qualifications:

• Proven track record in getting registrations approved in countries under responsibility
• Extensive experience in working across a wide range of regulatory systems and databases
• Experience from a multi-national or regional company is required
• Experience in Pharma, Cosmetics & Consumer Healthcare products is preferred
• Fluent (read and write) in the French language
• Professional knowledge of Sub-Saharan Africa regulations, North Africa, and European legislation
• Knowledge of legal and industry requirements, including standards, policies, and procedures
• Project management skills, including executing project plans and strategies
• Planning and organization skills, including developing systems to organize and track information
• Attention to detail, including double-checking information and work product
• Team participation, including offering relevant input to team discussions and solutions
• Ethical behavior, including recognizing and confronting potentially unethical behavior