Associate Director RA-Pharm Intelligence (BB-36F63)
Found in: Neuvoo CN
Summary of Job Responsibilities:
(Please use 2 to 3 sentences to summarize the purpose of the job.)
1.Monitor the regulatory environment (draft and final legislations/ guidelines and other information on drug development and regulatory matters issued by the Health Authorities)
2.Identify those that may have a business impact and lead or coordinate the assessment. And Communicate the identified documents and their potential impact within the Pharma Development organization (mainly Regulatory Affairs) as well as other relevant business functions within the Janssen.
3.Develop relationship with selected external industry associations, Regulators and other pharmaceutical companies to exchange Information, Identify and influence regulatory HAs and Industry trade association (link RAPAC) initiatives.
4.Provide regulatory expertise on regulatory competitor information related to regulatory submission strategies and bases for approvals in close cooperation with other relevant functions for selected projects.
5.Maintain an effective Regulatory Intelligence database, providing Regulatory Intelligence expertise regarding regulatory requirements and competitor environment for development projects and for marketed products, to allow Regulatory Affairs functions to anticipate and effectively implement new regulatory compliance obligations.
Dimensions of Job:
(Please provide quantitative indicators on which the job has impact – e.g., earnings, revenue, budget, staffing, etc. Include indicator that best represents the main purpose of Job.)
1.Regulatory intelligence support for RA department, China RND and business department.
2.Regulatory intelligence input to BU and product teams
3.Liaise with Regulatory agency and Industry trade association
Principal Accountabilities of Job:
(Please list 6 to 8 major responsibilities/objectives of the job in order of importance.)
1.Provide regulatory expertise for the RND organization (mainly Regulatory Affairs) to understand and keep abreast of any new regulatory developments and thereby to develop effective regulatory submission strategies and maintain compliance.
2.Anticipating new regulatory legislation and guidelines that may impact on the company Portfolio and influencing this.
3.Provide insight into the competition dealing with the regulatory Environment
4.Coordinate internal discussion to revision of regulations, guidelines.
5.Develop internal regulatory process for effective operation.
6.Credo based behavior with regulatory compliance excellence.
Key Performance Measures:
(Please list the key performance measures of this job)
1.Good HA connection and leadership
2.Good English skills, oral and written
3.Ability to influence, to build relationships with regulatory bodies, associations and stakeholders, and to successfully negotiate
4.Others: Crisis management.
1. Bachelor’s or above degree in chemistry, pharmaceutics, biology or a related life-science discipline. Advanced degree is preferred.
2. Strong oral & written communication skill; ability to work under pressure.
3. In-depth knowledge of regulatory environment, regulations and guidelines.
4. Ability to communicate regulatory plan and strategy to local teams. Experience in working in project teams and/or a matrix organization.
5. Proficiency in verbal and written English; good computer skill, good presentation skill.
calendar_today1 day ago
work Johnson & Johnson