Project Manager, Global Regulatory Affairs Compliance and Planning

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 disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

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 development 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 be responsible for ensuring global compliance and planning initiatives are implemented locally when applicable.  
•    The Project Manager will lead or support projects within the Global Compliance and Planning function and other appropriate project management initiatives within RA.
•    This role requires close partnership between global and regional regulatory functions as well as cross functional stakeholders such as QA, PV, and IT.  
•    This individual will 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.
•    The Project Manager will lead the project planning process and ensure strategic business objectives are met by the most efficient use of budget and resources.  This role will be required to think outside the box in developing a strategy and executing on a project effectively.  
•    This role will lead GRA risk management tracking initiatives. 
•    Support regulatory audits and inspections. Ensure effective processes are in place for tracking CAPAs, deviations.
•    Lead cross functional and regional collaborations to create harmonized processes and SOPs, including conducting a GAP analysis. 
•    This individual will develop performance metrics and conduct timely monitoring and reporting of project performance.
This role will be responsible for driving excellence in the execution of project role out and maintenance.

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

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

Non-Technical Skills
Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. Strong work ethic is required. Excellent problem-solving skills. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Working Conditions:

Requires up to 5% domestic and international travel

The anticipated salary for this position will be $155,000 to $170,000.  The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for S