Scientist - Regulatory Affairs

Overview of 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.

Your Team
This role reports to the Senior Manager Regulatory Affairs Middle East & Africa and will be responsible for Middle East and Africa countries.

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 local manager, to coordinate day-to-day Regulatory Affairs activities for specific areas of responsibility.
• Understand the regulatory landscape across the Middle East, monitor the regulatory environment, and provide assessments of the impact of new and changing regulations on the company's areas of interest.
• Handle compliance within the department by ensuring global, regional, and local processes, policies, SOPs, and working instructions are in place and adhered to.
• Coordinate, compile, and submit regulatory submissions, responses to regulatory agencies' questions, and other correspondence in accordance with regulatory agency regulations and guidelines and the country-specific requirements.
• Use substantial discretion and best practices to improve products or services based on knowledge of internal or external business issues.
• Utilize specialist knowledge, analytical skills, judgment, and broad conceptual and practical experience to solve complex problems and contribute to process improvements.
• Understand how different teams jointly achieve the objectives of the area and increase effectiveness using knowledge of the organization, processes, customers, and key business drivers.

Core Regulatory Practices

• Prepare and submit registration dossiers to achieve registration for the specific product portfolio within agreed timelines.
• Update and maintain dossiers post-registration to ensure compliance with corporate and health authority legal requirements, including submission of variation documents.
• Ensure renewal of registration of products by defining the accurate timelines.
• Maintain and update regulatory files and records, including appropriate archiving of all relevant documentation in line with applicable internal company standards.
• Review and ensure the conformity of product artworks, promotional material, and tools with the marketing code and legal requirements.
• Liaise with health authorities, distributors, and regulatory authorities to achieve and maintain registrations.
• Lead, monitor, assess, and communicate risks on key projects, providing regular updates to stakeholders and management.
• Monitor progress of applications against set timelines, acting where necessary to minimize delays and anticipate difficulties or challenges.
• Communicate information and present status updates on product/project activities to key internal and external stakeholders when requested.

Role Requirements
Qualifications & Technical Skills

• A minimum of a bachelor’s degree in pharmacy.
• 0-1 years of experience in Pharmaceutical/Personal Healthcare regulatory experience.
• Language proficiency: Arabic/English.
• Location: Dubai/UAE.

Soft Skills

• Experience in Pharma and/or Consumer Healthcare products.
• Excellent oral and written communication skills.
• Collaborative individual with the ability to establish relationships across departments to handle and deliver departmental results.

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.