Global Regulatory Affairs Compliance and Planning 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 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 $135,000 to $145,000.  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 Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing [email protected]. Controller’s data protection officer can be contacted at [email protected]. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at [email protected].

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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