R&D- GRA- Associate Regulatory Affairs Manager - BJ

Resiponsible for new product registration projects and LCM of marketed products in China:

• Discuss and set up registration strategies and timeline. Keep close communication with the project team for registration status update or related issue, and set up follow up/ mitigation plans.

• Contact headquarter for the registration of materials such as dossiers, reagent/samples, and the other related documents; Ensure the documents comply with the requirements of Chinese regulation or technical guidelines.

• Translate ，edit and check the application documents for submission and submit to CFDA.

• Liaise with government authorities to follow up the schedules for evaluation, quality assessment etc.

• To conduct within the company budget and timeframe the process of certificate renewal and supplementary registration and ensure the ongoing validity of these certificates.

• To Communicate/follow up/obtain the testing reports from NIFDC, and solve the problem happened in QC tests.

To coordinate with other departments such as Medical and Marketing Department during the registration process to share necessary information for registration.

To maintain efficient and durable relationships with government authorities such as NMPA, NIFDC, CDE, CCFIDE to ensure a smooth registration process.

Eusure compliance during the all registration activities.

The jobholder faces an evolving legislation and changing regulations on vaccine administration. Therefore, he/she needs to keep updating his/her knowledge on the latest regulations.

He/she should be able to considerate problem and control project process independently and systematically. Provide decisional suggestions and has strong executive force.

What you should have?

• Bachelor’s degree or above in clinical medicine or pharmacy

• >=3 years in RA experience and industry experience

• Knowledge of registration regulation and procedures in NMPA, NIFDC, CDE, and ICH guidelines

• Good command of English (written and spoken)

If you are a person demonstrate respect, teamwork, courage and intergrity with special focus on below competency:.

• Good analytical abilities and attention to detail

• Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity

• Ability to deal with multi-cultural environments

Team player with good communication, negotiation and influencial skills