We are looking for a passionate and experienced Senior Manager to join our Global Development Quality & Regulatory Compliance team as the Global Development Quality Lead for Japan (GDQL-J). In this key role, you will lead quality and compliance initiatives within our local affiliate operations, supporting GCP, GVP, Medical, and Regulatory Affairs. This position offers an exciting opportunity to create strategic partnerships, drive proactive, risk-based quality activities, and foster a culture of continuous improvement. If you are ready to make a meaningful impact and grow with us, we encourage you to apply.
A Typical Day:
In this dynamic role, you will:
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Lead GVP-compliant quality activities in collaboration with the business and GDQM team.
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Provide expert guidance on inspection readiness, preparation, and management at the local affiliate level.
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Partner with cross-functional teams to implement and sustain quality processes.
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Conduct audits and support issue management related to GVP, GCP, Regulatory, and Medical Affairs.
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Mentor, coach, and manage junior team members, fostering their professional growth.
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Collaborate with local and global stakeholders to align quality strategies and operations.
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Act as a subject matter expert in GCP and GVP, providing training and consultations.
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Drive process improvement initiatives to enhance efficiency and compliance.
This Role May Be For You If:
You are someone who:
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Thrives in a collaborative environment and builds strong stakeholder relationships.
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Has a proactive approach to quality management and risk assessment.
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Excels in managing complex quality issues and compliance activities.
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Enjoys mentoring and developing team members to achieve their full potential.
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Is detail-oriented and committed to maintaining the highest standards of quality.
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Values innovation and continuous learning to stay ahead in the pharmaceutical industry.
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Communicates effectively and influences peers and senior leaders alike.
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Is adept at managing multiple priorities and delivering results under tight deadlines.
To Be Considered:
Candidates must have a Bachelor’s degree and at least 8 years of relevant experience in the healthcare or pharmaceutical industry, with a strong background in quality management or clinical development. Advanced knowledge of GCP and GVP guidelines, along with experience in regulatory inspection management, is essential. Preferred qualifications include expertise in risk-based quality management and proficiency in Microsoft Office tools. Native level Japanese proficiency and business level English proficiency is required.
This is your chance to be part of a team that values integrity, innovation, and excellence. Join us in shaping the future of quality and compliance in the pharmaceutical industry. Apply today!
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.
