Job Description

• 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.