北京招聘

RESPONSIBILITIES:

• Support the line manager to prepare and execute consultation meeting with healthy authority on clinical development and registration strategy for the assigned projects

• Provide regulatory and guideline analysis to facilitate the line manager to work out the registration strategy for obtaining fastest possible development and approval of new projects.

• Work with the line manager/project team to define the regulatory timeline and the necessary technical documents to support CTA/NDA

• Follow up with cross function to require registration documents, track registration process and make projects going smoothly.

• Implement registration plan, prepare and submit registration dossier on schedule.

• Prepare technical documents and coordinate internal resources to ensure successful audit by HA like research audit, GMP audit, GCP audit, GLP audit, etc.

• Prepare QC validation testing materials and related documents, and follow up test process to ensure timely complete.

• Cooperate with marketing team and upper management team to design and modify Chinese artworks for package insert, pack and label, in line with relevant regulatory requirements.

• Execute all activities to ensure regulatory compliance in China

• Maintain good working relationships with regulatory authorities (CFDA, CDE, institute for drug control, and so on).

• Assist line manager to complete other assignment as requested in a time manner.

Requirements:

• Over 5 years working experience in regulatory affairs; and working experience in international company is preferred

• Sufficient experience to support or independently lead new drug CTA or/and NDA from preparation to final approval

• Experience for new drug development stratigic planning and cross-functional project coordiantions are a plus.

• Good knowledge of CFDA regulations and guidelines;

• Good command of written and orally English and Mandarin

• Good communication skill;

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。