Regulatory Affairs (Senior) Manager

Regulatory Affairs (Senior) Manager
Beijing


Purpose:
The purpose of this role is to plan, organize an******** registrationprojects ass******** an******** product registration an********activities.

Responsibilitie********
• Under the general direction of superv******** independently performproduct registration an******** activities.
- Participate in the development of regulatory affairs strategyan******** plan.
- Compile registration dossier an******** timely regulatory submissionupon internal review an********.
- Communicate with regulatory agencie******** (e.g., CFDA, PFDA,CDE,NIFDC, CPC,Coast Drug Control Institutes) on product reg********including but not limite******** regulatory ******** review committeemeet******** sample testing.
- Timely /closely monitor regulations an******** process for ensuringthe data presente******** represent what is practically require********the constantly changing regulations to be followed. Ensure earliestpossible registration.
- Properly maintain all regulatory documentation.

• Cross Functional
- Provide regulatory expertise to the new product launch activity ifnecessary
- Provide inputs an******** in the development of study protocol interms of regulatory requirement.
- Provide expertise from regulatory point of view to ensure marketsupply import an******** inspection complying with local regulation.

• Participate in development an******** regulatory affairs SOPan******** functional system
• Ensure compliance with Company regulatory pol******** principles ＆procedures an******** local team is aware an******** on these aspects;

• Perform a******** projects or assignments

• ALRP delegates with the labeling responsibilities are responsible forbelow dutie********
- Affiliate product information complies with regional an********regulatory requirements
- The update******** product information is submitte******** the localMOH within the designate********
- Gol******** informe******** the date of regulatory submissionan******** of regulatory acceptance/approval
- Affiliate Product Information for markete******** is maintained
- Agreements with Regulatory Authorities regarding submitte********Product Information are documente******** communicate******** GoLD
- The appropriate Quality unit is notifie******** labeling errors todetermine if labeling assessment report shoul******** complete********GQS132-Health Hazar******** (HHE)
Minimum Qualification Requiremen********
• At least bachelor degree in pharmaceutical orchemical/biopharmaceutical sciences.
• At least 4-year experience in drug regulatory affairs in globe leadingpharmaceutical company.
• Goo******** an******** management skills.
• Goo******** of English wr******** speaking/listening skill an********operation skill.
• Goo******** player.
• Self motivated.