Manager, Regulatory Affairs CMC
Who We Are From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases. SUMMARY:This position will be responsible for supporting Regulatory CMC capability in Japan for a portfolio of BioMarin products, 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.This includes supporting the global CMC strategy for the Global Regulatory Plan, with input from regional regulatory representatives and CMC SMEs; preparing CMC documentation to support global regulatory filings, including liaising with GRT regional representatives and relevant SMEs to draft technical content for CMC. RESPONSIBILITIES:Proactively managing CMC aspects of assigned projects including overseeing preparation and submission of CMC submissions in Japan, including clinical trial applications.Ensuring that CMC content is complete, well-written, and meets all relevant requirements.Evaluating proposed manufacturing changes for impact to ongoing and existing filings and provides strategic regulatory guidance for optimal implementation of changes.Researching and interpreting CMC regulations and providing regulatory guidance to the Quality, Manufacturing, Process Development and other functional groups.Representing the Regulatory Affairs CMC function on assigned cross-functional project teams.Supporting interactions with PMDA and other global regulatory authorities for assigned project to ensure acceptance, rapid review and approval of clinical trial applications and other submissions which present CMC information.Developing excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners. REQUIREMENTS:Bachelor’s degree in Pharmacy, Biology, Chemistry or related Sciences disciplines.With at least 3-5 years’ experience in Regulatory Affairs CMC with biotechnology or pharmaceutical companiesDemonstrated knowledge and understanding of the Japanese Regulatory environment.Must possess a thorough understanding of relevant drug development and post-marketing regulations and guidelinesMust 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 timelinesExperience in working with different project and functional area teams; and interacting with regulatory authoritiesMust be fluent in English and Japanese, both verbal and writtenProficiency 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 PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. 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.
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