Associate Registration Manager

Data Science Jobs

Prepare regulatory submissions
Analyze data packages
Maintain contact with regulatory agencies
Collaborate and communicate with China P BG President on ways to help the country meet annual objectives of different BUs and ensure regulatory support for marketing and sales efforts

Job Summary

  • Collaborate and communicate with China P BG President on ways to help the country meet annual objectives of different BUs and ensure regulatory support for marketing and sales efforts.
  • Prepare the regulatory submissions for registration of new products, variations to marketed products and clinical trial applications, critically analyze data packages for regulatory compliance, and develop an overall perspective of registration projects.
  • Maintain contact with officials of Chinese regulatory agencies to determine regulatory requirements, ensure compliance with regulations, and expedite approvals, while also maintaining an up-to-date knowledge of relevant legislation in China.

Matching Summary

Collaborate and communicate with China P BG President on ways to help the country meet annual objectives of different BUs and ensure regulatory support for marketing and sales efforts.

Skills & Requirements

Must-have

  • prepare regulatory submissions
  • analyze data packages
  • maintain contact with regulatory agencies
  • update local product documentation
  • maintain knowledge of China legislation
  • provide regulatory advice

Nice-to-have

  • collaborate with cross-functional teams
  • participate in special projects
  • ensure timely communication of requirements

Key Requirements

  • Regulatory Affairs experience
  • Product registration experience
  • Knowledge of China GMP
  • Knowledge of Chinese Pharmacopeia

Work Rights

Not specified

Tailored Resume

Cover Letter