Regulatory Affairs Associate Scientist
Procter & Gamble
- Johannesburg, Gauteng
- Permanent
- Full-time
- Defining the 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.
- 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.
- Experience from a multi-national or regional company is required
- Experience in Pharma, Cosmetics & Consumer Healthcare products is proffered.
- 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 or requirements of specific external bodies; Understands the rationale behind standards set and can anticipate likely changes or demands, which may affect on 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.