Regulatory Affairs Specialist, Beijing

申请这个职位

Primary Function

  1. IND, NDA, supplemental application submission.

Major Responsibilities and Duties

  1. Interact with health authorities through drug registration process.
  2. Follow up and push the progress.
  3. Assist to cope with the requirements from authorities.

Second Function

  1. RA intelligence.

Major Responsibilities and Duties

  1. Follow up new regulatory policies and assess potential impact.

Third Function

  1. Other RA specialist function.

Major Responsibilities and Duties

  1. Assist on formal and informal consultation meetings with CFDA.
  2. Other tasks assigned by line manager.

Qualifications:

  1. Bachelor or above in pharmacy, clinical pharmacology or related field.
  2. Acquainted with China drug registration regulation and process.
  3. At least 3-year regulatory filling experience.
  4. Good communication skill.
  5. Chinese and English (proficient), computer skill: word, excel, power point.