Regulatory Affairs Manager at Procter & Gamble

• To ensure compliance of the product portfolio to applicable regulations, guidelines, and Company standards across Sub-Sahara Africa (the region).
• Set up and implement Regulatory strategy regarding the local Life Cycle Management and local registration of new products across the region. Plan and coordinate the preparation & submission of registration and compliance dossiers. Follow and achieve registrations for the product portfolio according to plan.
• To advise 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, distributors, regulatory authorities, trade associations and contract manufacturers in Southern Africa, 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. To provide relevant regulatory advice in product development projects.
• To keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional, and local environment to ensure organizational compliance.

Qualifications

• A minimum of bachelor’s degree in a health-related science, life science or Pharmacy degree.
• Minimum 5 years of Regulatory Affairs experience:
• In depth technical regulatory knowledge in pharmaceutical development, OTC products, medical devices, food supplements, and demonstrated thorough understanding local regulatory requirements for countries under responsibility (5 + years).
• Proven track record in getting registrations approved in countries under scope of responsibility.
• Extensive experience in working across a wide range of regulatory systems and databases.
• Good oral and written communication skills in English for common business are a must
• Able to work independently, multi-task and perform in a challenging environment.
• Excellent problem-solving skills and uses data to connect multiple ideas and develop solutions.
• Strong interpersonal and communication skills to connect with people from different cultures and levels, both internally and externally.