Regulatory Affairs Associate Manager

Full Time Health Care
  • Full Time
  • Health Care
  • Dubai - United Arab Emirates
  • Attractive Salary AED / Month
  • Salary: Attractive Salary
  • Years of Experience: 3-5 Years Pharmaceutical/ Personal Healthcare Regulatory Experience

Website Procter & Gamble (P&G)

Our brands are trusted in millions of living rooms, kitchens, laundry rooms, and bathrooms—and have been passed down from generation to generation. We are the people behind the brands you trust, and we’re committed to making peoples’ lives better in small but meaningful ways, every day.

Regulatory Affairs Associate Manager

Job Location


Job Description

Implement Regulatory Strategies/activities across Sub Saharan Africa & Middle East countries for Personal Healthcare, products to meet Business & Regulatory requirements.

Your team

This role reports to Regulatory Affairs Director Africa & Middle east, and will look after French speaking, Sub Saharan Africa and Middle East countries.

Functional performance – Choose success metrics that reflect work processes for an employee to get the job done. Supervising how well an employee performs his job iscruciall to maintaining a driven business

Revenue and profits – Build success metrics that reflect the revenue and profits your employee generates. It’s common for positions that directly affect revenue and profits to have commissions or bonuses tied to them e.g. SLS

Time-based performance – Stipulate success metrics that are time-specific. Choose measures that require detailed changes in performance over time

Employee growth – Set metrics that challenge your employee from the beginning, encouraging them to reach towards peak performance.

Responsibilities of the role

  • 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.

Job Qualifications

Role Requirements

  • A minimum of a bachelor’s degree in health-related science, life science, pharmacy, or medical degree
  • Years of Experience: 3-5 Years Pharmaceutical/ Personal Healthcare Regulatory Experience
  • 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.
  • Extensive experience in working across a wide range of regulatory systems and databases.
  • Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result.

Soft skills

  • 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.
  • Uses specialist knowledge, analytical skills, judgment, and broad conceptual and practical experience to tackle sophisticated problems and to give to process improvements
  • Understands how the different teams jointly achieve the objectives of the area and uses knowledge of the organization, processes, customers, and key business drivers to increase efficiency.

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