Regulatory Affairs Associate Scientist - Sandton - Procter & Gamble

Description

Description

• To prepare and submit registration dossiers for Procter & Gamble Personal Healthcare portfolio and geographic territory within agreed timelines. This includes:
• Defining requirements for local submission of registration dossiers for FSA, Sub-Saharan Africa, and North Africa countries.
• Dossier compilation, authoring, regulatory compliance, and publishing using electronic databases and repositories for FSA, Sub-Saharan Africa, and North Africa countries.
• Submission of registration dossiers through third parties to achieve registration.
• To update and maintain dossiers post-registration, ensuring compliance with corporate and health authority legal requirements. This will include the submission of variation documents.
• To ensure retention and/or renewal of product registrations by defining accurate timelines.
• To ensure maintenance and update of regulatory files and records, including appropriate archiving of all relevant documentation in systems according to internal company standards.
• To advise the organization on potential regulatory risks during normal day-to-day activities and recommend compliant actions.
• To review and ensure conformity of product artworks, promotional materials, and tools with marketing codes and legal requirements.
• To liaise with health authorities in countries under responsibility to achieve and maintain registrations.
• To develop relationships with regulatory and industry bodies to represent the interests of the organization, gain relevant information, and help shape change.
• Maintain and provide required licenses for proper functioning of the company, such as GMP certificates, manufacturing licenses, CPPs (of country of reference), special functioning licenses.
• To provide relevant regulatory advice during product development for international markets.
• To stay up-to-date with dynamic regulatory, compliance, and statutory requirements in the global, regional, and local environment to ensure organizational compliance.
• Strategic input and support to Regulatory Affairs Director Middle East & Africa Cluster on local/regional/global Regulatory Affairs objectives aligned with commercial objectives for countries under responsibility.
• To update and maintain 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:

Language: English/African & French is a must

Work Experience:

• In-depth technical regulatory knowledge in pharmaceutical development, OTC, and Rx products, medical devices, Health products, and 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 Sub-Saharan Africa regulations, North Africa, and European legislation.
• Knowledge of legal and industry requirements: Has a broad knowledge and/or specialized knowledge or 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 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, including Neurobion, Sangobion, Vicks, Always, Ariel, Gillette, Head & Shoulders, Herbal Essences, Oral-B, Pampers, Pantene, Tampax, and more. Our community includes operations in approximately 70 countries worldwide.

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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

R000106712

Job Segmentation

Experienced Professionals (Job Segmentation)