Regulatory Affairs Compliance and Planning- Project Manager

Kyowa Kirin is a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. The North America organization includes two offices (in New Jersey and California) that focus on drug discovery, product development, and commercialization. Together, we work as a close-knit team to understand clinical needs and advance innovations that can have a profound impact on patient lives.

Summary:

The Project Manager, Global Regulatory Affairs Compliance and Planning will lead or support regional and global projects by effectively delivering assigned projects within GRA on time and within budget.   
This individual will support the develop of performance metrics and tracking mechanisms for timely monitoring and reporting of project performance.

Essential Functions:

The Project Manager, Regulatory Affairs Global Compliance and Planning is responsible for driving implementation of and adherence to best practices in project management.

•    This role will be a regional NA lead for Global Compliance and Planning and is responsible for ensuring global compliance and planning initiatives are implemented locally when applicable.  
•    Manage or support projects within the Global Compliance and Planning function and other appropriate project management initiatives within GRA.
•    Close partnership between global and regional regulatory functions as well as cross functional stakeholders such as QA, PV, and IT.  
•    Partner with GRA Compliance and Planning team members to deliver on the strategy of achieving industry leadership, process efficiency, standardization, and ingraining a cultural mindset of continuous improvement.
•    Lead the project planning process and ensure strategic business objectives are met by the most efficient use of budget and resources.  
•    Lead GRA risk management tracking initiatives. 
•    Support regulatory inspection readiness and regulatory audit inquiries.
•    Collaborate with Compliance and Planning team in the conduct of SOP and work instruction GAP analysis to ensure aligned global and regional processes.  
•    Develop performance metrics and conduct timely monitoring and reporting of project performance.
•    Responsible for driving excellence in the execution of project role out and training. 

Requirements:

Education
Bachelor’s degree.  PMP Certified Prior experience in Life sciences industry (Pharmaceutical, Medical Device, or Bio-Tech) is beneficial but not required.

Experience
5 years of pharmaceutical experience.  Broad understanding of pharmaceutical development, Regulatory Affairs, Quality Assurance, Safety and Commercial.  Experience 
managing cross-functional teams in a global business
environment is required. Experience implementing change management is also an important experience for this role.  

Technical Skills
Proficient in MS Office Suite (e.g, Microsoft Project, Powerpoint, Excel).

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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