Regulatory Affairs Officer

- Facilitate the internal and external regulatory activities with the objective of smoothly registering/re-registering and maintaining all the products in compliance with local legislations and business needs.

- Train staff in regulatory policies or procedures.

- Develop and maintain standard operating procedures or local working practices.

- Establish regulatory priorities or budgets and allocate resources and workloads.

- Manage activities such as audits, regulatory agency inspections, or product recalls.

- Participate in the development or implementation of clinical trial protocols.

- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.

- Develop regulatory strategies and implementation plans for the preparation and submission of new products.

- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.

- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.

- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

- Contribute to the development or implementation of business unit strategic and operating plans.

- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.

- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.

- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability.

- Closely monitor and provide updates on the local regulatory environment by ensuring adequate regulatory intelligence communication to internal stakeholders.

- Coordinate internal discoveries and depositions with legal department staff.

- Support on Certificate of Conformity (CoC) arrangements per country regulations.

- Build a strong client base for the company and develop new business opportunities to support the growth of the company.

- Maintain and nurture relationships with government, associated authorities, and all committees.

- Supervise document management for registrations, tenders, and customer requests.

- Monitor regulatory affairs trends that are related to environmental issues.

- Provide support to businesses and work in close cooperation with all relevant units/departments.

- Liaise and assist top-notch multi-national corporate clients of diverse product portfolios in compliance and regulatory requirements.

Employment Type

Full Time

Company Industry

• Perfumery
• Toiletries
• Personal Care
• Cosmetics

Department / Functional Area

Keywords

• Regulatory Affairs
• Legal