MEA Regulatory Affairs Lead – Pharma Submissions

Procter & Gamble; Dubai; On-site; AED 240,000 - 360,000; Full time

Job summary

Procter & Gamble in Dubai seeks a Regulatory Affairs professional to drive strategic regulatory initiatives for the Middle East & Africa. You will develop regulatory strategies, execute product submissions, and ensure compliance across markets, enabling timely market access.

The role requires detailed regulatory planning, excellent communication, and collaboration with cross-functional teams to integrate regulatory considerations into product development and business processes.

Qualifications

• Bachelor's degree in Pharmacy is required.
• 0-1 years in Pharmaceutical/Personal Healthcare regulatory experience.
• Languages: Arabic and English.
• Location: Dubai, UAE.

Responsibilities

• 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.
• 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.

Skills

Regulatory Affairs

Communication

Pharma knowledge

Arabic

English

Education

Bachelor's degree in Pharmacy

Job description

Procter & Gamble in Dubai seeks a Regulatory Affairs professional to drive strategic regulatory initiatives for the Middle East & Africa. You will develop regulatory strategies, execute product submissions, and ensure compliance across markets, enabling timely market access.

The role requires detailed regulatory planning, excellent communication, and collaboration with cross-functional teams to integrate regulatory considerations into product development and business processes.