Regulatory Affairs Executive

As a Regulatory Affairs Executive, you will play a crucial role in ensuring compliance with regulatory requirements for our products and operations. You will be responsible for coordinating and preparing regulatory documents, submissions, and registrations. This role requires attention to detail, strong organizational skills, and the ability to work effectively across departments to meet regulatory timelines and objectives.

Key Responsibilities:

1. Regulatory Submissions: Prepare and submit regulatory documents such as product registrations, notifications, and applications to regulatory authorities.
2. Compliance Monitoring: Stay updated with changes in regulatory requirements and ensure our products and processes align with local and international regulations.
3. Documentation Management: Maintain accurate regulatory files and documentation to support compliance activities.
4. Cross-functional Collaboration: Work closely with research and development, quality assurance, and marketing teams to ensure regulatory requirements are met from product development to market launch.
5. Regulatory Strategy: Provide regulatory guidance and support to internal stakeholders on product development, labelling, and promotional materials.
6. Audits and Inspections: Assist in regulatory audits and inspections by providing necessary documentation and support.
7. Quality Assurance: Collaborate with the quality assurance team to address regulatory issues and implement corrective actions.

Requirements & Skills:

1. Bachelor’s degree in a scientific discipline (e.g., biology, chemistry, pharmacy, nutrition, food science, food technology) or related field.
2. Proven experience in regulatory affairs.
3. Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA).
4. Excellent communication skills and ability to work effectively in a team environment.
5. Detail-oriented with strong analytical and problem-solving abilities.
6. Ability to manage multiple projects and prioritize tasks effectively.
7. Candidates MUST BE fluent in Mandarin as the role requires the candidate to work with products that are marketed in Mandarin.