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Regulatory Affairs Associate Scientist
1-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:
- 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 some cases, submission of registration dossiers through third parties to achieve registration.
2-To update and maintain dossiers post registration, to ensure compliance with corporate and health authority legal requirements. This will include the submission of variation documents.
3- To ensure the retention and/or renewal of registration of products by defining the accurate timelines.
4-To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards.
5-To advise the organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
6-To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.
7-To liaise with health authorities in countries under responsibility to achieve and maintain registrations.
8-To develop relationships with regulatory and industry bodies to represent the interests of the organization, gain relevant information and help shape change.
9- Maintain and provide required licenses for proper functioning of the company, like GMP certificate, manufacturing license, CPPs (of country of reference), special functioning licenses.
10-Provide relevant regulatory advice in product development of products for international markets.
11-To keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance.
12- 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.
13-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.
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/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 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.
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, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Pampers®, Pantene® and more. Our community includes operations in approximately 70 countries worldwide.
Visit http://www.pg.com 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, disability, or any other legally protected factor.
Procter & Gamble
Our goal is to use every opportunity we have —no matter how small— to set change in motion. To be a force for good and a force for growth. For you, for the world, and for every generation to come.
Rivonia, Gauteng, South Africa Job Type: Full time Job categories: Research And Development Req No: R000100544
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