RA supervisor
Summary of Job Responsibilities:
1. Handles registration projects for new product and CMC variations according to the regulations and registration plan.
2. Provides regulatory and technical support to other departments, including Q&A, R&D, Supply Chain, Marketing etc.
3. Shapes healthcare environment.
Principal Accountabilities of Job:
1. Ensures successful execution of regulatory strategy and submission for registration projects；
2. Provides guidance and advice to function departments on regulatory affairs to ensure registration projects completed timely.
3. Regulatory assessment of Change Control to ensure the compliance
4. Interact with HA officials.
5. Pay close attention to regulations, guidelines and develops internal policies and procedures.
6. Actively involved in Cross functional activities
1. Handles registration projects for new product and CMC variations according to the regulations and registration plan.
2. Provides regulatory and technical support to other departments, including Q&A, R&D, Supply Chain, Marketing etc.
3. Shapes healthcare environment.
Principal Accountabilities of Job:
1. Ensures successful execution of regulatory strategy and submission for registration projects；
2. Provides guidance and advice to function departments on regulatory affairs to ensure registration projects completed timely.
3. Regulatory assessment of Change Control to ensure the compliance
4. Interact with HA officials.
5. Pay close attention to regulations, guidelines and develops internal policies and procedures.
6. Actively involved in Cross functional activities
1. A university degree major in chemistry, pharmaceutics, biology or a related life-science discipline， biologics is preferable.
2. At least 5 years of regulatory affair experience in a pharmaceutical plant.
3. High learning ability and willing to work under stress and face challenges.
4. Have good communication with HA.
5. Good English in verbal and written
2. At least 5 years of regulatory affair experience in a pharmaceutical plant.
3. High learning ability and willing to work under stress and face challenges.
4. Have good communication with HA.
5. Good English in verbal and written