JOB DESCRIPTION
Job Title:
Senior Manager, International Regulatory Affairs
Department / Cost Center:
Regulatory – 210
Reports to (Job Title):
Head of APAC Regulatory Affairs
Job Code:
Location:
Tokyo
Date Prepared:
February 2025
Full-Time Part-Time
Regular Temporary
Exempt Non-Exempt
State the overall function or purpose of the job.
We are seeking a highly motivated, energetic professional capable of working effectively in fast-paced environment to join our International Regulatory Affairs team. This position will be responsible for developing the strategy, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for BioMarin products, interfacing with the Japanese regulatory authorities (e.g. MHLW, PMDA), and for providing insight and support for clinical development in Japan. This position is based in the Tokyo office.
RESPONSIBILITIES
List the major responsibilities of the job.
Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. Play an active role in leading the strategic planning and preparation of complex submissions including but not limited to the following: JNDA/JsNDA (content development, assembly of the dossier, submission through approval); post-marketing maintenance including re-examinations, JAN applications, expedited pathway applications and any other required submissions in Japan. Must ensure all submissions are prepared in accordance with Japanese regulations. Serve as primary liaison with the regulatory authorities (e.g., MHLW, PMDA) and interface on behalf of BioMarin to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Lead in preparation for and execution of agency meetings.
Actively participate in multi-functional global team environment, and interface closely with U.S. and other global BioMarin offices to align on operational and strategic deliverables.
Evaluate new and emerging regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s products or plans.
EDUCATION
State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
A bachelor of science degree in life science.
Qualified Pharmacist is a plus.
Fluent in Japanese and English.
EXPERIENCE
State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Minimum of ten years of industry experience with at least six years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including good knowledge and understanding of the Japanese regulatory environment.
Proven track record for preparing, submitting, and gaining approvals for JNDAs.
The candidate is expected to have a thorough understanding of relevant drug development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities.
Experience as clinical scientist and/or in-depth understanding of clinical development as a regulatory strategist is highly desired.
Proficiency with computer and standard software programs is required. The candidate is expected to be fluent in English, both verbal and written (technical). Strong collaborative skills are needed as this position requires close working relationships with stakeholders both inside and outside of the company. Good verbal, written and presentation skills are also required.
CONTACTS
List the key positions, internal and external, with which the job incumbent must interact.
The candidate must interact with Japan team members, International team members, and colleagues based in the global company headquarters.
BioMarin is Headquartered in California.
The position will report directly to the Head of APAC Regulatory Affairs based in Tokyo.
SUPERVISOR RESPONSIBILITY
List the number of personnel directly reporting to this position and their job titles. List the number of personnel functionally reporting to this position (i.e., supervised on a “dotted-line” basis), and their job titles. Specify the total number of personnel supervised by this position, both directly and through others.
No direct reports.
Skills Required
- Bachelor of Science degree in life science or equivalent experience
- Fluency in Japanese and English, including technical written English
- At least 10 years of industry experience
- At least 6 years of Regulatory Affairs experience in the biotechnology or pharmaceutical industries
- Good knowledge and understanding of the Japanese regulatory environment
- Proven experience preparing, submitting, and obtaining approvals for JNDAs
- Thorough understanding of relevant drug development regulations and guidelines
- Strong interpersonal, written, verbal, communication, presentation, planning, and coordination skills
- Proficiency with computers and standard software programs
- Qualified Pharmacist
- Experience as a clinical scientist or in-depth understanding of clinical development as a regulatory strategist
BioMarin Pharmaceutical Inc. Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about BioMarin Pharmaceutical Inc. and has not been reviewed or approved by BioMarin Pharmaceutical Inc..
-
Healthcare Strength — Benefits are often characterized as comprehensive, spanning medical, dental, vision, life and disability coverage, along with FSAs/HSAs and an EAP. Feedback suggests these health offerings are consistently regarded as strong and at times "industry best".
-
Leave & Time Off Breadth — Leave and time off are described as generous, with structured vacation progression, dedicated sick time, and a company-observed winter break among many holidays. Feedback suggests this breadth of paid time away is a standout element of the total rewards.
-
Retirement Support — Retirement support is underpinned by a 401(k) savings plan with a company match. Feedback suggests these retirement programs contribute meaningfully to overall compensation value.
BioMarin Pharmaceutical Inc. Insights
What We Do
Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact. Recruitment Fraud Alert Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral. In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity. If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit. We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.
