- 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.
-
Senior Scientist/research Manager in An
3 days ago
AgriViro (Pty) Ltd Sandton, South Africa**Senior Scientist/Research Manager in an Innovative Agricultural Biotechnology Company** · **About the position** · This Senior Scientist/Research Manager position is an exciting position in an innovative agricultural biotechnology (AgBio) company. AgriViro is committed to provi ...
Regulatory Affairs Associate Scientist - Sandton, South Africa - Procter & Gamble
Description
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:
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:
Job specific competencies & Skills :
Job Schedule
Full timeJob Number
RJob Segmentation
Experienced Professionals (Job Segmentation)