Regulatory Affairs Associate Manager P&G Dubai

Procter & Gamble

Regulatory Affairs Associate Manager at P&G in X346+RXG, Jebel Ali Freezone, Dubai, UAE will implement Regulatory Strategies/activities across Sub Saharan Africa & Middle East countries for Personal Healthcare, products to meet Business & Regulatory requirements. This is a Senior level full time job. And salary can range between 13000-25000 AED/month.

Responsibilities of Regulatory Affairs Associate Manager

  • To prepare and submit registration dossiers to achieve registration for 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.
  • 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 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 system in line with applicable internal company standards
  • 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. And trade associations to achieve and maintain registrations.
  • To develop relationships with regulatory bodies to represent the interests of the organization, gain relevant information and help craft change.
  • Leads, monitors, assesses. And communicates risks on key projects, providing regular updates to Stakeholders and Senior Management
  • Monitors and progress of applications against set timelines, acting where vital, to minimize delays and anticipate difficulties/challenges.
  • Communicates information and presents status updates on product/project activities to key internal/external partners when requested.

Requirements for Role of Regulatory Affairs Associate Manager

  • Bachelor’s degree in health-related science, life science, pharmacy, or medical degree.
  • 3-5 Years experience in Pharmaceutical/ Personal Healthcare Regulatory.
  • Extensive experience in working across a wide range of regulatory systems and databases.

Skills And Knowledge Desired

  • Language: Arabic/English, French is a must
  • In depth technical regulatory knowledge in pharmaceutical development, OTC and Rx products, medical devices, Health products & food supplements proven detailed understanding of local regulatory requirements for countries under responsibility.
  • Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result.
  • Work autonomously, but in alignment with local manager, to coordinate day-to-day Regulatory Affairs activities for specific area(s) of responsibility.
  • Understands the regulatory landscape, Monitors the regulatory environment and provides assessments of the impact of new and changing regulations on the company’s areas of interest.
  • Handles compliance within the department by ensuring global, regional, and local processes, policies, SOPs and working instructions are in place and adhered to.
  • Handles the coordination, compilation and submission of regulatory submissions, responses to regulatory agencies questions. And other correspondence in accordance with regulatory agency regulations and guidelines and the country specific requirements
  • Works with substantial discretion and uses standard processes and knowledge of internal or external business issues to improve products or services.

Assistant Executive P&G Dubai

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