Regulatory Affairs Associate Manager Procter & Gamble Dubai
Full time @Procter & Gamble posted 2 months ago in Retail Shortlist Email JobJob Detail
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Job ID 17499
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Career Level Senior
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Experience 3 Years
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Gender Male Female
Job Description
Regulatory Affairs Associate Manager at Procter & Gamble will implement Regulatory Strategies/activities across Middle East & Africa (MEA) 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 Middle East & Africa countries including dossier compilation, authoring, regulatory compliance, and publishing using electronic databases and repositories.
- 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
- A minimum of a bachelor’s degree in health-related science, life science, pharmacy, or medical degree.
- 3-4 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: Proficiency in Arabic & English are 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.
- 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.
- 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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