Manager, Regulatory Affairs Japan

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 18 hours ago

Vacancies: 1 Vacancy

Job Summary

As part of our global expansion we are now looking for in-country regulatory professionals to join our growing global regulatory team. This is an exciting opportunity to demonstrate your knowledge in leading regulatory processes for biological products and regenerative medicines in Japan and to build Regenerons profile with key stakeholders locally.

In this unique position you will interact with a wide and diverse range of colleagues across Regeneron both locally and globally.

Key duties:

Execute the timely submissions of marketing applications and post-approval changes for assigned projects
Work with Japan Regulatory Lead to manage and oversee interactions with Japanese regulatory authorities
Maintain extensive knowledge of Japans Submission Requirements
Ensure compliance with Japans regulatory requirements and all appropriate local standards
Lead/support the timely preparation and submission of clinical trial applications to PMDA
Collaborate with and represent regulatory as part of a local multi-disciplinary team including clinical commercial medical and patient safety colleagues
Assist the development of local labelling and patient information for assigned programs
Co-ordinate regulatory review of promotional materials as and when needed

Essential:

Bachelors degree in an appropriate scientific discipline
Experienced (approx. 5 years) regulatory professional having managed major submissions and approvals in Japan
Knowledge of clinical trial requirements and ability to problem-solve local procedures
Ability to advise on clinical aspects of local requirements will be a major advantage
Ability to think strategically sound commercial awareness and excellent communication skills both verbally and in written form in English.
Ability to thrive in and foster strong matrix team working in a global environment
Negotiation skills with Japanese Health Authorities
High fluency in English

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 Companys 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.

Required Experience:

Manager

In this unique position you will interact with a wide and diverse range of colleagues across Regeneron both locally and globally.

Key duties:

Execute the timely submissions of marketing applications and post-approval changes for assigned projects
Work with Japan Regulatory Lead to manage and oversee interactions with Japanese regulatory authorities
Maintain extensive knowledge of Japans Submission Requirements
Ensure compliance with Japans regulatory requirements and all appropriate local standards
Lead/support the timely preparation and submission of clinical trial applications to PMDA
Collaborate with and represent regulatory as part of a local multi-disciplinary team including clinical commercial medical and patient safety colleagues
Assist the development of local labelling and patient information for assigned programs
Co-ordinate regulatory review of promotional materials as and when needed

Essential:

Bachelors degree in an appropriate scientific discipline
Experienced (approx. 5 years) regulatory professional having managed major submissions and approvals in Japan
Knowledge of clinical trial requirements and ability to problem-solve local procedures
Ability to advise on clinical aspects of local requirements will be a major advantage
Ability to think strategically sound commercial awareness and excellent communication skills both verbally and in written form in English.
Ability to thrive in and foster strong matrix team working in a global environment
Negotiation skills with Japanese Health Authorities
High fluency in English