Regulatory Affairs Associate Scientist

To prepare and submit registration dossiers and to achieve registration for the specific product brand categories under Procter & Gamble Personal Healthcare portfolio and or geographic territory, within agreed timelines.

This includes:

1. Defining the requirements for local submission of registration dossiers for FSA, Sub-Saharan Africa, and North Africa countries.
2. Dossier compilation, authoring, regulatory compliance, and publishing using electronic databases and repositories for FSA, Sub-Saharan Africa and North Africa countries.
3. Submission of registration dossiers through third parties to achieve registration.
4. Updating and maintaining dossiers post registration to ensure compliance with corporate and health authority legal requirements, including the submission of variation documents.
5. Ensuring the retention and/or renewal of registration of products by defining the accurate timelines.
6. Maintaining and updating regulatory files and records including appropriate archiving of all relevant documentation in line with applicable internal company standards.
7. Advising the organization of potential regulatory risks in normal day to day activities and recommending compliant actions.
8. Reviewing and ensuring the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.
9. Liaising with health authorities in countries under responsibility to achieve and maintain registrations.
10. Developing relationships with regulatory and industry bodies to represent the interests of the organization, gain relevant information and help shape change.
11. Maintaining and providing required licenses for proper functioning of the company, like GMP certificate, manufacturing license, CPPs (of country of reference), special functioning licenses.
12. Providing relevant regulatory advice in product development of products for international markets.
13. Keeping abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment to ensure organizational compliance.
14. Providing strategic input and support to Regulatory Affairs Director Middle East & Africa Cluster on local/regional/global Regulatory Affairs objectives in alignment with commercial objectives for countries under responsibility.
15. Updating and maintaining all regulatory and tracking systems as well as other databases with relevant current information and activity dates for all products as required.

Job Qualifications

Education: A minimum of a bachelor's degree in health-related science, life science, pharmacy or medical degree.

Location: Johannesburg, South Africa

Languages: English / Africans & French is a must

Work Experience: In-depth technical regulatory knowledge in pharmaceutical development, OTC and Rx products, medical devices, health products & food supplements demonstrated thorough understanding of local regulatory requirements for countries under responsibility. Proven track record in getting registrations approved in countries under responsibility. Extensive experience in working across a wide range of regulatory systems and databases.

Job Specific Competencies & Skills

Experience from a multi-national or regional company is required. Experience in Pharma, Cosmetics & Consumer Healthcare products is preferred.

Professional Knowledge

Keeps up-to-date on current theory and practice in both educational and own professional field. Makes self-available to others to help address professional issues. Fluent (read and write) in the French language. Professional knowledge of the Sub-Saharan Africa regulations, North Africa, and European legislation.

Knowledge of Legal and Industry Requirements

Has a broad knowledge and/or specialized knowledge of requirements of specific external bodies; understands the rationale behind standards set and can anticipate likely changes or demands, which may affect work.

Professional and Technical Expertise

Advanced professional. Expert knowledge and application of professional/technical concepts and principles normally associated with a professional or academic qualification or a detailed grasp of involved practices and procedures and extensive experience and application. Recognized across the organization and beyond as an expert in their field.

Quality Assurance

Optimizing adherence to procedures.

Knowledge of Processes, Standards, Policies and Procedures

Knowledge of industry professional best practice in business processes, performance standards, policies and procedures.

Project Management

Executes projects, executes individually, project plans/strategies which have been developed by someone else.

Planning and Organization

Develops systems to organize and keep track of information. Sets priorities with an appropriate sense of what is important.

Attention to Detail

Double checks the accuracy of information and work product. Careful monitors the detail and quality of work. Expresses concern that things be done right, thorough, and precisely.

Team Participation

Demonstrates clear awareness of issues facing the team and the objectives. Consistently offers relevant input to team discussions and solutions being developed.

Ethical Behavior

Recognizes when situations or directives are directly or indirectly in conflict with professional ethics. Confronts potentially unethical behavior; does not look the other way or ignore such occurrences.

About Us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands.

Our community includes operations in approximately 70 countries worldwide. Visit to know more. Our consumers are diverse and our talents - internally - mirror this diversity to best serve it. That is why we're committed to building a winning culture based on Inclusion and our ideal candidate is passionate about the same principle: you will join our daily effort of being "in touch" so we craft brands and products to improve the lives of the world's consumers now and in the future. We want you to inspire us with your unrivaled ideas. We are committed to providing equal opportunities in employment. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, veteran status, HIV/AIDS status, or any other legally protected factor.

Job Schedule: Full time

Job Number: RExperienced Professionals (Job Segmentation)