Regulatory Administrative Manager, Regulatory Affairs
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
Job Title: Regulatory Administrative Manager, Regulatory Affairs
Job Description: Regulatory Administrative Manager will support all Regulatory Affairs personnel in the Tokyo BioMarin office and will oversee regulatory administrative related activities and document support related activities. This will include planning, scheduling, formatting, QC, PDF creation, transmitting, and paper and electronic archiving of regulatory submissions and archiving of all Health Authority communication and correspondence using BioMarin controlled systems.
- Manage timelines as required, and track status of submissions and project assignments; provide status updates, metrics, and other communications to Project Teams.
- Participate in Regulatory teams as needed to ensure adequate follow-up Technical support; interface with Regulatory Operations as needed for support and guidance.
- Maintain Japan specific submission templates and tools for generation of regulatory documentation.
- Assemble processed regulatory documentation for submissions, including New Drug Applications, Prior Change Applications, Minor Change Notifications, and all Health Authority correspondence, including Q&A documents and written/oral communications.
- As needed, prepare hardcopy documents, and prepare submissions, including photocopying, assembly, QC, and prepare for delivery, or transportation of hardcopy documents for clinical, CMC and labeling.
- Support archiving of regulatory documents (paper and electronic) from interactions with MHLW / PMDA.
- Support development of local processes for submission and document management in collaboration with Global regulatory process and local requirements.
- Prepare electronic media, such as flexible discs (e.g. CD, DVD) as needed for submissions.
- Support the Gateway administrator for JNDA submissions and FD application system for CMC / other business license submissions. and stay ahead of changes in regulatory guidance related to electronic submissions and systems.
- Support business license maintenance activity such as MAH and Wholesale distributor (e.g. admin assistant; support management pharmacist to record and archive records for training kit of medical devices.
- At least 3-5 years of experience in a regulated industry managing regulatory documentation.
- Experience in the pharmaceutical field preferred.
- Must be highly proficient in MS Office 2016 (with an emphasis on MS Word) and Adobe Acrobat (version XI Pro or DC preferred). Strong knowledge of eDMS such as VEEVA.
- Knowledge of computer systems, electronic document management systems such as Veeva, and database management preferred.
- Outstanding interpersonal and communication (written and verbal) skills is required.
- Able to work in a matrix team environment, such as cross-functional groups in Regulatory Affairs, Clinical Development, Pharmacovigilence, etc.
- Attention to detail and ability to manage multiple projects; Project management skills are a plus.
- Native Japanese with proficiency in English language (reading and writing and preferably verbal).
- Bachelor’s degree in Pharmacy, Biology, Chemistry or related Sciences disciplines preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.