Regulatory Affairs Associate Scientist - Rivonia
Procter & Gamble
Job Location Rivonia-Johannesburg Job Description 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. 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/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. Job Schedule Full time Job Number R000100544 Job Segmentation Experienced Professionals (Job Segmentation) P&G was founded over 180 years ago as a simple soap and candle company. Today, we're the world's largest consumer goods company and home to iconic, trusted brands that make life a little bit easier in small but meaningful ways. We've spanned three centuries thanks to three simple ideas: leadership, innovation and citizenship. The insight, innovation and passion of talented teams has helped us grow into a global company that is governed responsibly and ethically, that is open and transparent, and that supports good causes and protects the environment. This is a place where you can be proud to work and do something that matters.
Apply Now
Facebook
WhatsappRelated Jobs
Regulatory Affairs Manager (Critical Care) - Crown Mines
...
Regulatory affairs pharmacist - Johannesburg
...
Senior Regulatory Affairs Pharmacist - Johannesburg
...
Regulatory Affairs Pharmacist Johannesburg - Johannesburg
MVG Recruitment Specialists
...
Regulatory Affairs Pharmacist Gauteng - Gauteng
MNA Recruitment
...