Associate Director, Regulatory Affairs Japan
Location Tokyo, Japan Workstyle Hybrid Apply
JOB DESCRIPTION
Job Title: | Associate Director, Regulatory Affairs Japan |
Department / CostCenter: | Regulatory – 210 |
Reports to (Job Title): | Head of APAC Regulatory Affairs |
Job Code: | |
Location: | Tokyo |
Date Prepared: | April 2024 |
Full-Time Part-Time | Regular Temporary | Exempt Non-Exempt |
SUMMARY DESCRIPTIONState 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 (MHLW and/or PMDA), and for providing insight and supportfor clinical developmentin Japan.Thispositionisbased in theTokyo 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 inleading 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 JP regulations. Serve as primary liaison with the Regulatory authorities (e.g., MHLW and/or PMDA) and interface on behalf of BioMarin to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Leadin preparation for and execution of Agency meetings. Evaluate new and emerging regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s productsor 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 a life science. Qualified Pharmacistis required. 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 tenyears of industry experience with at least eightyears of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of theJapanese 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 developmentregulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Proficiency with computer and standard software programs is required. Candidate must 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. Excellent 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 Japanteam 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 APACRegulatory 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 directreports. |