About the Job
In this role, you will be a key driver behind our continued growth and success. With our commitment to innovation, you will seek out, develop, and help implement strategic initiatives for improved efficiency and productivity. From creating regulatory affairs strategies to executing product submissions and registrations across the Middle East and Africa, you need to be a detailed planner, excellent communicator, and expert in regulatory affairs. You will be dedicated to ensuring regulatory compliance and facilitating market access for our products, navigating complex regulatory landscapes with precision and expertise.
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Your Team
This role reports to the Senior Manager of Regulatory Affairs for the Middle East & Africa and will manage responsibilities for multiple countries within that region.
How Success Looks Like
- You understand regulatory requirements deeply and apply them effectively to ensure compliance across the Middle East and Africa markets.
- You execute and implement regulatory strategies that streamline product submissions and registrations, resulting in timely market access and minimal delays.
- You provide strategic guidance and 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.
- You effectively foster a culture of excellence, collaboration, and professional growth within the regulatory affairs function and the company.
Responsibilities of the Role
- Work autonomously, but in alignment with the local manager, to coordinate day-to-day Regulatory Affairs activities for specific areas of responsibility.
- Understand and monitor the regulatory landscape across the Middle East, providing assessments of the impact of new and changing regulations on the company's areas of interest.
- Ensure compliance within the department by adhering to global, regional, and local processes, policies, and standard operating procedures (SOPs).
- Coordinate, compile, and submit regulatory submissions and responses to regulatory agencies’ questions in accordance with regulations and country-specific requirements.
- Utilize specialist knowledge, analytical skills, and judgment to solve complex problems and contribute to process improvements.
- Understand how different teams jointly achieve objectives and leverage knowledge of the organization, processes, customers, and key business drivers to increase effectiveness.
Core Regulatory Practices
- Prepare and submit registration dossiers to achieve product registration within agreed timelines.
- Update and maintain dossiers post-registration to ensure compliance with corporate and health authority legal requirements, including the submission of variation documents.
- Define accurate timelines to ensure timely renewal of product registrations.
- Maintain and update regulatory files and records, archiving all relevant documentation in line with applicable internal standards.
- Review product artworks, promotional material, and tools for conformity with marketing code and legal requirements.
- Liaise with health authorities, distributors, and regulatory agencies to achieve and maintain registrations.
- Lead, monitor, assess, and communicate risks on key projects, providing regular updates to stakeholders and management.
- Monitor the progress of applications against set timelines and act where necessary to minimize delays and anticipate challenges.
- Communicate information and present status updates on product/project activities to key internal and external stakeholders as requested.
Role Requirements
Qualifications & Technical Skills
- A minimum of a bachelor’s degree in pharmacy.
- 0-1 years of experience in Pharmaceutical or Personal Healthcare Regulatory Affairs.
- Proficiency in Arabic and English.
- Based in Dubai, UAE.
Soft Skills
- Experience in Pharmaceutical and/or Consumer Healthcare products.
- Excellent oral and written communication skills.
- Collaborative team player with the ability to build relationships across departments to ensure departmental success.
Job Schedule
Full time
Job Segmentation
Entry Level
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.
