Senior Manager/Associate Director, International Regulatory Affairs Tokyo, Japan Hybrid

Job description

SUMMARY DESCRIPTION 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 (e.g. MHLW, PMDA), and for providing insight and support for clinical development in Japan. This position is based in the Tokyo office. RESPONSIBILITIES Develop Japanese Regulatory filing strategies and identify risks and potential gating factors. Play an active role in leading 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 Japanese regulations. Serve as primary liaison with the regulatory authorities (e.g., MHLW, PMDA) and interface on behalf of BioMarin to negotiate as needed to support plans for new drug registrations and activities for existing product licenses. Lead in preparation for and execution of agency meetings. Actively participate in multi-functional global team environment, and interface closely with U.S. and other global BioMarin offices to align on operational and strategic deliverables. Evaluate new and emerging regulations/guidance to advise BioMarin on the Japanese Regulatory environment and changes that could impact BioMarin’s products or plans. EDUCATION A bachelor of science degree in life science. Qualified Pharmacist is a plus. Fluent in Japanese and English. EXPERIENCE Minimum of ten years of industry experience with at least six years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including good knowledge and understanding of the Japanese 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 development regulations and guidelines and to have outstanding interpersonal and communication (written and verbal) skills and effective task planning and coordination abilities. Experience as clinical scientist and/or in-depth understanding of clinical development as a regulatory strategist is highly desired. Proficiency with computer and standard software programs is required. The candidate is expected to 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. Good verbal, written and presentation skills are also required. CONTACTS The candidate must interact with Japan team 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 APAC Regulatory Affairs based in Tokyo. SUPERVISOR RESPONSIBILITY No direct reports. 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