宜兴招聘

Requirements:
Robust knowledge of global regulatory requirements for registering pharmaceutical or medical device products (combination product knowledge is an advantage)
Proven ability to apply the regulations to submission of the Quality section of MAAs (e.g., CTD Module 3), device applications, Design History Files and/or Tech Files.
Working regulatory knowledge of drugs and/or medical device manufacturing
Understanding of product/process quality standards, including risk management
Good scientific knowledge and technical system skills
Ability to manage multiple complex projects and timelines in a matrix team environment
Demonstrated interpersonal and collaboration skills, including strong negotiation skills
Strong oral and written communication and presentation skills(English required)
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Minimum of 4 years regulatory experience in RA or related field, including managing people or projects
BS degree or equivalent in related field, but relevant post graduate degree is preferred
Some travel may be required

Job Descriptions:
Participate as local regulatory representative at Suzhou R&D Center to support projects/product development and lifecycle management for commercial products globally
Develop regulatory strategy and CMC (Quality/CTD Module 3) submission content for initial product submissions and CMC changes , according to company timelines
Review and assess changes proposed to products in collaboration with China Regulatory Affairs ; liaise with manufacturing plants and Quality as needed
Support inspections or Agency meetings conducted by/ Health authorities at Suzhou Global R&D Center
Educate R&D personnel on regulatory affairs CMC requirements
Communicate with Global and International regulatory teams
Capture local/regional regulatory requirements to inform/educate the global teams
Facilitate/contribute to corporate’s Policy and Positions on CMC Standards
Participate in external CMC forums/trade associations (including China)
Participate with Quality and MP R&D in Suzhou site change control meetings.

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