Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Global Development Quality Lead – Japan, to join our Global Development Quality & Regulatory Compliance team, supporting our Japan affiliate in a hybrid work model. In this role, you will drive quality and compliance in local operations by providing expert guidance and leadership for the Regeneron quality management system supporting GCP, GVP, Medical and Regulatory Affairs. You will collaborate with cross-functional teams and key stakeholders across local and global functions. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Location: Japan
Work model: Hybrid
Discover your role:
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Lead quality and compliance activities for GCP, GVP, Medical and Regulatory Affairs at the Japan affiliate.
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Build strategic partnerships and drive proactive, risk-based quality initiatives, including audits, with key stakeholders.
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Optimize inspection readiness and support inspection preparation for local affiliate operations.
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Contribute to process improvement initiatives and lead projects aligned with quality objectives.
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Manage issue resolution and escalate serious non-compliances through established processes.
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Provide expert guidance, training, and support on international regulations and Regeneron standards.
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Line manage, coach, and mentor junior team members or serve as process owner, as assigned.
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You exemplify a quality mindset, professional conduct, and continuous learning in all interactions.
This role requires:
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Bachelor’s degree (or equivalent experience) and at least 8 years of relevant healthcare/pharmaceutical industry experience.
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Advanced knowledge and application of GCP and/or GVP guidelines, including managing complex quality and compliance issues.
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Experience in quality/compliance or clinical development roles, with expertise in GCP/GVP.
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Proven ability in training, supervising, line management, and staff development.
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Strong project management, planning, prioritization, and time management skills.
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Advanced digital literacy, including Microsoft Office suite.
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Effective communication and stakeholder engagement skills, with ability to influence senior leaders.
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Demonstrated ability to manage multiple priorities with urgency and attention to detail.
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Understanding of risk-based quality management and process improvement.
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Behavioral strengths including integrity, adaptability, critical thinking, and collaborative problem solving.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
