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Regulatory Affairs Manager - Middle East

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Summary of the job:

  • Execute Regulatory Strategies/activities across Middle East countries for Personal Healthcare, products to meet Business & Regulatory requirements.

  • 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 across Middle East, 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 best practices 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 solve complex problems and to contribute 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 effectiveness.

Core Regulatory Practices: ·

  • To prepare & submit registration dossiers and to achieve registration for the specific product portfolio, within agreed timelines. ·

  • 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 shape 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 necessary, to minimize delays and anticipate difficulties/challenges. ·

  • Communicates information and presents status updates on product/project activities to key internal/external stakeholders when requested.

  • Life Science Degree or equivalent qualification with a major in pharmaceuticals
  • Years of Experience: 5-6 Years Pharmaceutical/ Personal Healthcare Regulatory Experience
  • Language: Arabic/English is a must
  • Location: Dubai-UAE
  • Experience from a multi-national or regional company is required
  • Experience in Pharma, Cosmetics & Consumer Healthcare products
  • In depth knowledge of Middle east, North Africa, and European legislation.
  • Excellent Oral & written communication skills
  • Team activity, collaborative individual and must have the ability to establish relationships across departments to handle and deliver departmental result

About us

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always®, Ariel®, Gillette®, Head & Shoulders®, Herbal Essences®, Oral-B®, Pampers®, Pantene®, Tampax® and more. Our community includes operations in approximately 70 countries worldwide.

Visit to know more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate against individuals on the basis of race, color, gender, age, national origin, religion, sexual orientation, gender identity or expression, marital status, citizenship, disability, HIV/AIDS status, or any other legally protected factor.

Job locations:
Dubai, Dubai, United Arab Emirates
Job Type: Full time Job categories: Research And Development Req No: R000081817
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