Johnson & Johnson Careers
Senior RA Manager
Requisition ID: 1805659744W
u Major Responsibilities/Activities:
l Develop and execute regulatory plans for complex projects including new product registrations and maintenance of licenses/authorizations for existing marketing authorizations and managing key product / manufacturing changes
l Lead the RA function on assigned cross-functional project teams by establishing appropriate and effective communication within RA and other functions and ensure that project objectives and deliverables are aligned with regulatory strategy and objectives are met
l Monitor and notify applicable regulatory requirement changes to ensure that company’s businesses are not negatively impacted and assure compliance with JJSV internal policies and external regulatory standards.
l Provide direct supervision of individuals in team. Coach and train team members so as to establish a strong RA team to support all business objectives.
l Build long-term and win-win relationship/partnership with all external customers (Officials of Provincial FDA, Test center, Center of medical device evaluation and National Standard & CFDA Industrial group….etc.)
l Perform regular gap analysis of existing regulatory and compliance processes and propose optimal solutions in the spirit of quality improvement in JJSV.
l Industry experiences: With a minimum of 7 -10 years regulatory experience in RA or related field, including
managing people or projects
l Position experiences: At least 4--5 years as team leader
l Language Skills：Good command of English (verbal and written forms)
l Computer Skills: Proficient in office software (powerpoint, excel, word, emails)
l Mobility: one Biz trip/per month at least
l Certificate Required: NO
l Other Special requirement:
Ability to manage and lead complex projects and timelines in a matrix team environment
Effective oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to independently identify compliance risks and escalate when necessary
AMO (Shanghai) Medical Devices Trading Co., Ltd. (7076)