Michael Page International Inc. Head of Regulatory Affairs in Boston, Massachusetts
Global Registration projects-Regulatory submissions and approval:
Responsible for innovative drug products to be registered and launch in US and China with a good time manner.
Define RA data Package and regulatory strategy according to target product profile, evaluate submission relevant documentation for regulatory compliance and suitability for registration, preparation of different types of regulatory submissions (e.g. import registration, variation and renewal), Understand and interpret complex project related issues, provide optimization advice, constructive suggestions based on regulation requirements and regulatory best practices.
Master both US and China regulations for product registration, efficiently collaborate internally and externally
Review non-promotional and educational materials to ensure compliance
Collect information on competitive products, provide regulatory supports and advice
Anticipates potential challenges in registration and changes in health care policies that could impact business and develop strategies to optimize the outcome If applicable, Regulatory Affairs (RA) contributes to relevant local guidelines and regulations' development that impact business, identifying trends and changes that may impact on the company.
Responsible for interactions and communications with authorities in China and worldwide (e.g. NMPA, FDA, etc.).
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
Bachelor's degree and above in pharmacy, pharmacology, chemistry or biological sciences.
Above 10 years' experience in drug development and regulatory affairs in multiple TAs are required, with extensive experience in managing major projects, in which at least 8 years of experience in direct contact with the local Regulatory Authorities.
Rich experience in and understanding of role of RA specially NDA experience and regulatory requirements in Biotech Industry including international requirements, e.g. ICH requirements and national requirements, e.g. NMPA or FDA requirements and have understanding of current trends.
In depth knowledge of drug development process, Regulatory obligations and guidelines in the country and region. Be able to think strategically and in long term perspectives.
Strong influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with representatives in Regulatory Authorities.
Specialized in disease biology, medicinal chemistry, and translational science to advance its novel and differentiated pipeline of drugs to address medical needs for metabolic and immune-related diseases.
Competitive compensation package and benefits.
Opportunity to over see all of Regulatory Affairs.
Michael Page International Inc.
- Michael Page International Inc. Jobs