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Regulatory Affairs Specialist (FSP)

Primary Location: China, Remote Additional Locations: Hong Kong, Remote 求人ID R0000034837 Category Regulatory / Consulting
応募

About this Role

Duties and responsibilities

  • Ensuring that products, operations, and business transactions follow all relevant legal and internal rules

  • Preparing and submitting documentation to regulatory authorities for approvals and licenses and ensuring that vitamins & minerals containing products abide by the requirement in food stipulated by government 

  • Supporting and coordinating with various departments during the development of a product to ensure regulatory compliance including the cross border products

  • Assisting with the organization of regulatory inspections and conducting internal audits whenever needed

  • Keeping up to date with changes in regulatory legislation and guidelines and being able to apply it and promulgate it within the corporation

  • Advising and guiding the team and other relevant departments on regulatory requirements and changes

  • Reviewing product promotional materials, labelling, batch records, specification sheets, quality control checks and validation protocols for compliance with regulatory standards

  • Maintaining comprehensive electronic and paper-based records of all regulatory affairs activities

  • Researching and collecting information about new and existing regulations and guidelines

Years of experience required:

  • 1- 2 years post graduate experience with prior studies in life sciences degree, e.g. Biology, Biochemistry

Basic attributes:effective communication skills, detail-oriented, being meticulous and willing to try out new projectsOther qualities include:

1. Effective Communication: The ability to convey complex regulatory requirements clearly to diverse audiences, both internally and externally.

2. Teamwork: Working collaboratively across departments like R&D, QA, and marketing to ensure compliance and successful product submissions.

3. Adaptability and agility: Staying flexible in a field where regulations and priorities can change rapidly.

4. Critical Thinking: Evaluating challenges thoughtfully and proposing logical solutions.

5. Time Management: Prioritizing tasks and meeting tight deadlines for regulatory submissions.

6. Ethical and Compliance Judgment: Upholding integrity in ensuring the close adherence to regulations and standards.

応募

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