As part of our global expansion, we are now looking to fill a critical role in our Japanese leadership team. The General Marketing Compliance Supervisor will possess the experience, and technical skills required for assignment as the " Sokatsu-Seizohanbai-Sekinin-Sha " according to Japanese Law. This is an exciting opportunity to demonstrate your knowledge in developing processes for Regeneron Japan, and to build Regeneron’s profile with key stakeholders locally.
JOB DUTIES:
- Act as the Sokatsu for the business in Japan to monitor the liability of the company in accordance with local laws
- Work closely with the business in Japan to secure the appropriate operating licenses
- Oversees the development and implementation of local processes and the quality system, in conjunction with local and global organization
- Represent the business in audits and inspections
- Provides oversight of local quality, regulatory and safety managers, within a matrix organisation
- Liaison for any quality agreements between global manufacturers
- Partnering with internal stakeholders locally and globally
- Maintains an up to date working knowledge of laws, regulations, and industry guidance that affect the business
- Continually monitor local changes in guidelines and legal requirements and perform necessary business impact assessments
- Communicate with Japanese health authorities (PMDA, MHLW) where necessary
- Work with colleagues to ensure local product release requirements are met, when required
- Establishes and maintains strong relationships with all functional areas of the local and global organization (such as safety, medical, marketing, sales/operations, legal, etc) to support business success
- Ability to work both independently and within project teams, committees, etc. to achieve business goals and objectives
JOB REQUIREMENTS:
- Degree in Bachelor's degree or higher in scientific or relevant field
- Meets requirements to be Soseki (pharmacy license, etc.)
- More than 3 years experiences in Soseki
- Deep understanding of RA and/or QA for biotech products
- Strong knowledge of current Japanese regulations and regulatory activities related to marketed products
- High fluency in English and Japanese
- Experience of establishing and developing new local entities of global companies will be a strong advantage
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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