Manager, Regulatory Affairs CMC
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.
This position will be responsible for overseeing the Regulatory CMC capability in Japan including the development of regulatory strategies, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance for small molecules and biologics products, and interfacing with the Japanese regulatory authorities (MHLW and / or PMDA).
- Oversee and manage the planning and preparation of complex submissions including but not limited to the following:
- JNDAs (including content development, QC, assembly of the dossier, submission, data integrity inspection, Q&A, through Module 1.2 and 2.3 etc.);
- Post--marketing maintenance including partial change applications, minor change notification including impact assessment of change requests, content development, QC, assembly of the dossier, submission, data integrity inspection, Q&A, through Module 1.2, 2.3 and new/old table etc.);
- JAN applications and any other required submissions in Japan;
- Must ensure all submissions are prepared in accordance with local regulations (e.g., biologics, accuracy of documents and JP requirements) and Interface closely with QA, CMC, regulatory, manufacturing, QC etc. in local, U.S. and other global BioMarin offices to align strategies
- Develop Japanese regulatory filing strategies including JNDA and life cycle management and identify risks and potential gating factors for both development and marketed products. Evaluate regulations / guidance and participate in industry trade organizations in order to advise on the Japanese Regulatory environment and changes that could impact company products or plans.
- Prepare regulatory intelligence reports to communicate any changes or updates on regulations to internal teams
- Serve as a 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. Assist in preparation for and execution of Agency meetings
- Manage product licenses and lifecycle, including maintaining as current the administrative and CMC sections
- Identify and manage local Japanese regulatory consultants and contractors, and liaise with them as needed for projects
- Collaborate with multi-functional global team, and clearly communicate RA/CMC activities to headquarters to ensure strategic alignment
- Bachelor’s degree in Pharmacy, Biology, Chemistry or related Sciences disciplines. PhD degree holder is preferable.
- With at least 5 years’ experience in Regulatory Affairs CMC with foreign-based biotechnology or pharmaceutical companies
- Demonstrated in-depth knowledge and understanding of the Japanese Regulatory environment
- Proven track record for preparing, submitting, and gaining approvals for JNDAs and post-marketing variations, particularly for biologics and/or orphan disease products
- Proven ability to manage major regulatory submissions (JNDAs) independently and prioritize multiple projects with competing timelines is required.
- Must possess a thorough understanding of relevant drug development and post-marketing regulations and guidelines
- Must possess excellent written and verbal communication skills in order to successfully liaise with and influence internal/external stakeholders, and communicate critical aspects of ongoing project activities while demonstrating awareness of global program priorities and competing timelines
- Experience in negotiating with MHLW and/or PMDA regarding product registrations, and other regulatory topics
- Experience in working with different project and functional area teams; and interacting with regulatory authorities
- Must be fluent in English and Japanese, both verbal and written
- Proficiency in MS Office (e.g. Word, Excel, Project)
- Up to 10% travel within Japan and to US and the other CMC related sites.
- Candidate with more relevant experience will be considered for the role of Senior Manager