Senior Associate, Regulatory Submissions

Responsibilitie********







•Prepare routine submissions file******** Regulatory Authorities (e.g.IND********, HGRAC, Import perm******** export permits an********) inChina.
•Will take ownership for specific pieces of work an******** be theRegulatory Affairs lea******** projects.
•Review/summarize/compile scientific/research documents in preparationfor submission to Regulatory Authorities.
•Assist in the coor******** collection an******** of data an********require******** Regulatory Authorities.
•Interact with the Publishing group, Copy Center or equivalent asnecessary for the production of submissions.
•Responsible for maintaining awareness of regulatory leg********guidance an******** pertaining to assigne**************** areas.
•Assure compliance with regulatory requirements in relation toassigne********.
•Participate in project development an******** strategy planningsessions. Will participate independently in client meetings an********proactively liaise with clients on regulatory submission issues.
•Work on special regulatory projects as assigned.







*Education/Qualifications

Bachelor’s Degree in Life Sciences or equivalent.




*Experience

Minimum Required:

？Excellent communication sk******** organization an******** skillsan******** to detail.

？Minimum of 3 years experience in the pharmaceutical industry preferablyin regulatory affairs or drug development.