Regulatory Affairs CMC Specialist

Job type:
on-site
Start:
n.a
Duration:
n.a
From:
Quanta Consultancy Services
Place:
Switzerland
Date:
07/28/2015
Country:
flag_no Switzerland

Project description:
Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
Regulatory Affairs CMC Specialist



World leading international Biopharmaceutical client currently requires support for their regulatory affairs team from a Regulatory specialist to provide support with developing a strategy for interactions with the Chinese authorities on a CMC biopharmaceutical product file.



- Discuss previous issues with authorities on the lifecycle management for the CMC dossier.

- Review CMC documentation for the biopharmaceutical product with respect to China pharmacopeia regulations.

- Help the client to make any necessary modifications to the CMC dossier.

- Support the client in setting a strategy for interactions with the Chinese authorities.

- Provide support with answering questions from health authorities.

- Makes proposals to the organization with regard to variations of chemical/pharmaceutical documents following questions from authorities.



Requirements:



- Biopharmaceutical background.

- Extensive experience in Regulatory Affairs.

- Previous experience in CMC essential – preferably within lifecycle maintenance for CMC dossier.

- Experience working with Chinese authorities essential.

- Good command of written and spoken English.

- Excellent communicator.