Associate Director, 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.
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 overseeing the strategy, preparation and execution of regulatory submissions (marketing applications (MAs) and post-marketing maintenance) for 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, assembly of the dossier, submission, through approval); post-marketing maintenance including partial change applications, clinical and nonclinical supplements, updates to foreign manufacturer accreditations (FMAs); JAN applications, and any other required submissions in Japan. Must ensure all submissions are prepared in accordance with JP regulations (e.g., biologics). Interface closely with U.S. and other global BioMarin offices to align strategies.
- Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. Evaluate regulations/guidances and participate in industry trade organizations in order to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s products or plans. Prepare regulatory intelligence reports to communicate any changes or updates on regulations to internal teams.
- 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. Assist in preparation for and execution of Agency meetings.
- Manage Japan product licenses and lifecycle, including maintaining as current the administrative, clinical, CMC, and nonclinical sections.
- Identify and manage local Japanese regulatory consultants and contractors, and liaise with them as needed for projects.
- Actively participate in multi-functional global team environment, and clearly communicate RA activities to headquarters to ensure strategic alignment.
- Expected to have at least 10 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including 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 negotiating with MHLW and/or PMDA regarding product registrations, orphan drugs, in-country testing requirements and other regulatory topics.
- Attendance at specified project and functional area team meetings. Interpersonal responsibilities will include working closely with project and other regulatory team members and interacting with regulatory authorities.
- Proficiency with computer and standard office software programs is required.
- Must be fluent in English and Japanese, both verbal and written (technical).
- Up to 10% travel expected within Japan and to US.
- Reports directly to the Sr. Director, Regulatory Affairs, APAC based in the Hong Kong. Liaise with the Global Regulatory CMC group based in headquarters.
BA/BS degree, life sciences preferred.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.