Regulatory Affairs Associate Manager
4 weeks ago
Working in a Regulatory Affairs role at Procter & Gamble means that you implement Regulatory activities across Middle East countries for Personal Healthcare products to meet Business & Regulatory requirements.
Your team
This role reports to the Director of Regulatory Affairs Middle East & Africa and will look after Middle East countries.
How Success Looks Like
You understand regulatory requirements & apply them effectively to ensure compliance across the Middle East and Africa markets.
You develop and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access and minimal delays.
You build and maintain positive relationships with regulatory authorities, demonstrating these connections to facilitate approvals and address any challenges.
You provide support to cross-functional teams, ensuring regulatory considerations are integrated into product development and business processes.
You proactively identify potential regulatory risks and develop strategies to ensure continuous compliance and business continuity.
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 compliance 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 progresses 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: Preferred 2-3 years of experience in pharmaceutical or Personal Healthcare Regulatory experience.
- Language: Fluent in Arabic & English is required.
- Work location: Dubai / UAE.
- Knowledge of Middle East, Africa, and European legislation.
- Candidate should have good negotiation skills and a collaborative approach, with the ability to establish relationships across departments.
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.
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.
Works with significant discretion and uses standard processes and knowledge of internal or external business issues to improve products or services.
Job Schedule: Full time
Job Number: R
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