OBJECTIVE/ PURPOSE OF THE JOB

The key objective of the Regulatory Affairs Specialist is to ensure that all products within the Beauty Division and the steps involved in registering, testing and marketing them, meet legislative requirements. Typical duties include; studying scientific and legal documents to ensure compliance with applicable laws and regulations within each respective country. They will be responsible on all compliance related matters within the Beauty Industry regulations by navigating the company through the governments continually changing policies and must ensure compliance and release of the product in the market on time. Overall, their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.

KEY RESPONSIBILITIES

• Navigating Regulatory Requirements : Staying abreast of evolving regulations and guidelines pertinent to the industry and ensuring products meet these standards.
• Documentation and Submission: Compiling, organizing, and submitting regulatory documentation required for product approvals, licenses, and permits.
• Communication Liaison: Serving as a liaison between the company and regulatory authorities, facilitating communication and addressing inquiries or concerns.
• Compliance Management: Monitoring and ensuring ongoing compliance with regulatory requirements throughout the product lifecycle, from brand onboarding to marketing and post-market surveillance.
• Risk Assessment: Conducting risk assessments to evaluate potential impacts of regulatory changes or non-compliance on product development and market approval.

Core Responsibilities

• Ensure that a Company’s products comply with the regulations of the regions where they want to distribute them
• Ensure the Company maintains compliance with all regulatory requirements and standards to protect consumer safety and company reputation
• Keeping up to date with regulatory changes to ensure that a company’s products comply with the regulations of the regions where they want to distribute them
• Advise the company on necessary adjustments and ensure all changes are carried out
• Ensure compliance with all relevant ISO standards in the region, including regulations for cosmetics and other beauty products
• Regularly reporting on compliance status and measures to both internal and external parties
• Explaining industry regulations, policies, and procedures to respective personnel
• Serve as the primary point of contact for regulatory agencies and address inquiries or issues
• Advising Division on regulatory and compliance matters
• Identifying and interpreting relevant regulatory guidelines for Division
• Evaluate applicable laws and regulations to determine impact on Company activities
• Studying scientific and legal documents to check they meet legal requirements
• Review product formulations to ensure a smooth approval process with authorities
• Providing technical reviews of reports for regulatory compliance
• Maintaining familiarity with Division product ranges
• Submitting information and responding to queries from medical bodies on Medical Cosmetics and Healthcare products with the Ministry of Health in the respective Countries
• Advise brand scientists and manufacturers on regulatory requirements
• Undertake and manage regulatory inspections
• Liaise with, and make presentations to, regulatory authorities
• Protect consumer safety and uphold the company’s reputation by ensuring all products meet legal and safety standards in the region
• Validates stock for daily distribution

Document Management, Recording and Audits

• Preparation of all the necessary documents for new product registration applications and for product registration renewal
• Reviews the data accuracy prepared for compliance and highlights variances to the respective manager
• Continually follows up on product registration submissions under review
• Managing regulated documentation for certifying bodies or government agencies
• Maintaining critical data related to regulatory compliance in databases or information systems
• Maintain detailed records of product ingredients and formulations for regulatory reporting
• Maintains a database of all product approvals and under approval with active status and keep a full compilation of records A-Z.
• Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency
• Participate in regulatory audits and inspections and implement corrective actions as needed

License Renewals

• Develop and write clear arguments and explanations for new product licenses and license renewals
• Prepare submissions of license variations and renewals to strict deadlines
• Monitor and set timelines for license variations and renewal approvals.

Marketing Compliance

• Presenting registration documents to regulatory agencies and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorization for the products concerned
• Provide accurate and timely action on product labeling to meet regulatory requirements.
• Write clear, accessible non-removable product labels in Arabic for over-labelling of products to comply with governmental standards
• Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
• Outline requirements for product storage.

Others

• Provide training to staff on regulatory requirements and best practices.
• Develops regulatory affairs SOP’s for the Division and ensures that it is adhered to

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