The Procter & Gamble Company (P&G) is an American multinational consumer goods corporation headquartered in Cincinnati, Ohio, founded in 1837 by William Procter and James Gamble. It specializes in a wide range of personal health/consumer health, personal care and hygiene products; these products are organized into several segments including beauty; grooming;...
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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.
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.
To ensure the retention and/or renewal of registration of products by defining the accurate timelines.
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.
To advise the organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code 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, like GMP certificate, manufacturing license, CPPs (of country of reference), special functioning licenses.
Provide relevant regulatory advice in product development of products for international markets.
To keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance.
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.
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.
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.
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