Regulatory Affairs Senior Manager P&G Dubai

Regulatory Affairs Senior Manager at P&G in X346+RXG, Jebel Ali Freezone, Dubai, UAE will reports to Director of Regulatory Affairs Middle East & Africa & will look after Middle East & North Africa countries. This is a Senior level full time job. And salary can range between 20000-40000 AED/month.

Responsibilities of Regulatory Affairs Senior Manager

• 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 & 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.

Requirements for Role of Regulatory Affairs Senior Manager

• A minimum of a bachelor’s degree in pharmacy, or medical degree.
• 10+ Years experience in Pharmaceutical/ Personal Healthcare Regulatory.
• Experience from a multi-national or regional company is required.
• Experience in Pharma & Consumer Healthcare products.

Skills And Knowledge Desired

• Arabic/English.
• 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.

Data Engineer P&G Dubai