Sr. Manager Regulatory Affairs

Responsibilities



● Ensure regulatory submissions meet appropriate standards andcontent requirements in China.



● Lead, manage and write regulatory annual updates and submissions.



● Manage and track regulatory authorities’ questions. Working withcross-functional teams to provide responses to the questions on time.Manage and track regulatory responses and commitments.



● Work effectively in cross-functional teams and support the teamobjectives in delivering project milestones.



● Ensure timely submission of regulatory submissions. Ensure timelyregulatory approvals in China.



● Support the development of regulatory strategies to enableaccelerated product development timeline.



● Establish SOPs and work flow and find creative ways to resolve problems.



Minimum Qualifications

● B.S. with 8+ years or M.S. with 5+ years’ experience in regulatoryaffairs for small biotech companies.



● Prior experience with drug IND/NDA/ANDA/sNDA/BLA in China required.



● Hands on experience in regulatory submissions for clinical stageprograms in China is required.



● Proficient in China NMPA/CDE and ICH requirements for new drugs.



● Proficient in Shanghai Local government requirements formanufacturing and commercializing new drugs.



● Knowledge in GLP, GMP and GCP regulations.



● Willing to contribute and add value to company’s bottom line.



Skills



Ability to work across organizational levels, able to effectivelynegotiate and influence, results focused.



Excellent verbal and written communication skills, ability tocollaborate with others,



Proven cross-functional leadership skills, ability to prioritize andadapt to change in a startup environment.



Self-motivated creative problem solver and can deal with ambiguity anddeclare a path forward to achieve results.



Strong computer skills, with proficiency in word processing,spreadsheet, presentation and PDF software.