Regulatory Affairs Specialists assist in obtaining and maintaining government approval for medicine, health product, medical devices, cosmetics & food supplement. The team who act as a liaison between governments (NHRA, MOH etc.). and consumers to help make sure that marketed products are imported and distributed in compliance with ministry regulations. The team negotiate the interaction between the regulators (the government), the regulated (principle company), and the market (consumers) to get good products in our Kingdom and to keep them persistent.
- Our Regulatory Personnel’s are efficiently bringing timely Product authorizations/approvals/ and close follow-up with the authorities.
- They work on document preparation, information management, file maintenance, and coordination of tasks across multiple departments.
- Part of their strategic directive is to achieve a balance between regulatory concerns, technology, marketing objectives, compliance, time to market, and costs.
- They help review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
- They determine the types of regulatory submissions or premarket regulatory requirements that are required.
- Team works in a dynamic environment where strict timelines and protocols should met.
- Team frequently work on managing and documenting information, and are in adept at working with databases and other information management tools.
- They work frequently with other employees and team members to coordinate complex activities, often with competing priorities.
- The range of issues addressed is huge, such as registration and renewal (of the registered item) & further to monitor safe & proper distribution. Advertising issues, with a healthy dose of data management, document preparation, issue negotiation, and conflict resolution, are operated in the mix.
- Keeping close track to regulatory changes and interpreting its implications on the product development and authorization process.
- Our team is with business skills and are able to integrate regulatory knowledge into business strategies and also exhibit sound judgment in Finance, Marketing and policy as well as making timely regulatory intelligence and strategy for the company.
- Our Regulatory Affairs team visits the Regulatory Bodies and has day today interaction with the officials and follows the cases on the regular basis for the smooth processing of the applications and timely approvals.
Key Duties include
- Explain regulations, policies, or procedures to MAH or principle company
- Recording & maintaining data in information systems or databases
- Ensure compliance with kingdom’s regulations
- Advise company on regulatory and compliance matters
- Evaluate applicable laws and regulations to determine impact on company activities
- Provide technical review of data or reports
- Coordinate regulatory documentation activities
- Identify and update MAH timely with relevant regulatory guidelines
- Ability to adapt quickly to changing regulations
- Advice about company policies, practices, and systems
- Obtaining and maintaining marketing permission
- Outlining requirements for labeling, storage, and packaging
- Providing advice about regulations to manufacturers/ Principals
- Ensuring that quality standards are met and submissions meet strict deadlines