Regulatory Affairs Associate Manager

Job Location

Dubai

Job Description

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

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 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.
  
  

Job Qualifications

Role Requirements

• A minimum of a bachelor’s degree in health-related science, life science, pharmacy, or medical degree
• Years of Experience: 3-4 Years Pharmaceutical/ Personal Healthcare Regulatory Experience
• 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.
• 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.
  
  

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 Neurobion, Sangobion, Vicks, Always, Ariel, Gillette, Head & Shoulders, Herbal Essences, Oral-B, Pampers, Pantene, Tampax and more. Our community includes operations in approximately 70 countries worldwide.

Visithttp://www.pg.comto 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 Schedule

Full time

Job Number

R000114103

Job Segmentation

Experienced Professionals (Job Segmentation)