Senior Regulatory Affairs Manager

Posting Date: 13 Sep 2024

Job Function: Corporate Affairs

Company: TC Red Bull (Beijing) Trading Co., Ltd.

Location: CN

T.C Pharma

Regulatory Strategy Development: Develop and implement comprehensive regulatory strategies that support the company's business objectives.
Regulatory Submissions: Prepare and submit regulatory submissions to relevant regulatory authorities, such as the MOH, FDA, SAMR.
Regulatory Compliance: Ensure that all company activities comply with applicable regulatory requirements, including labeling, advertising, and safety standards.
Regulatory Updates: Monitor and stay informed about changes in regulatory requirements and their impact on the company's operations.
Risk Assessment: Conduct risk assessments to identify potential regulatory risks and develop mitigation strategies.

Stakeholder Management: Collaborate with internal and external stakeholders, including regulatory authorities, legal counsel, and business units, to ensure effective regulatory compliance.
Regulatory Intelligence: Gather and analyze regulatory intelligence to identify emerging trends and opportunities.
Regulatory Training: Provide regulatory training and education to employees across the organization.

By effectively managing regulatory affairs, Senior Regulatory Affairs Managers contribute to the company's overall success and ensure that its products and services are safe, effective, and compliant with applicable regulations.

Knowledge of specific regulatory requirements, such as Good Manufacturing Practices (GMP) or Good Clinical Practices (GCP).
Proficiency in relevant regulatory software and databases.