Assoc. Dir. Regulatory Affairs

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Primary purpose and function of this position:

• Is responsible for developing the regulatory strategy, preparation and execution of regulatory submissions (HA consultation documents, Clinical Trial Notification (CTN), Marketing applications (MAs) for Teva's innovative products with various tactics to expedite product registrations.
• Requires a strong understanding and knowledge of local regulatory requirements, and also actual experience of leading regulatory activities in Japan (e.g. CTN, PMDA consultation, J-NDA dossier preparation and filing).
• Need a strong communication skills and built excellent trust-based relationship with HAs (e.g. MHLW, PMDA) and with various internal stakeholders (Incl. Innovative Medicines Regulatory Affairs, Global development teams and Japan team).
• The Associate Director of Innovative Medicines Regulatory Affairs in Japan will lead the document preparation process (incl. Briefing Packages, CTN documents, J-NDA dossier) to ensure high quality and timely submission as per the agreed workplan.

How you’ll spend your day

• Accountable for the development and implementation of regulatory strategies in Japan. Create proactive and robust regulatory strategies for development products considering the global regulatory strategy, through the discussion with the Global project team, Global Regulatory Lead (GRL), Innovative Medicines Regulatory Affairs and Japan team members. Recommend such strategies to team members and senior management.
• Lead, implement and drive the regional regulatory strategy & submission activities, including the planning, coordination and submission of Briefing Packages, meeting requests, CTNs, J-NDAs and other regulatory filings to ensure compliance with local regulatory standards.
• Coordinate and lead the team in planning, preparation (incl. Briefing Packages), and execution for meetings or teleconferences with HAs in Japan.
• Coordinate responses to HAs with appropriate personnel and departments to resolve outstanding regulatory issues.
• Ensure that cross-functional activities to support submissions are in compliance with regulatory requirements, to achieve timely submissions. Identify gaps and propose/support solutions to address them that are consistent with regulatory requirements. Initiation and/or participation in teleconferences and/or meetings related to the topic/project (to clarify issues, solve issues, discuss changes and strategy, check timelines and availability of documents, etc.).
• Represent Innovative Medicines Regulatory Affairs in Japan in global teams (Global Regulatory Strategy Team (GRST), project team, portfolio/commercial team, etc.) and provide regulatory filing strategy and guidance in Japan.
• Assessment of business development opportunities from Japan regulatory perspective.
• Update internal electronic systems as applicable.
• Follows all Teva applicable policies and procedures.
• Other duties as assigned or as business needs required.

Your experience and qualifications

• Required: BSc/MSc in chemistry/biology/biotechnology/pharmacy or similar scientific field
• At least 5 years of experience in regulatory affairs for pharmaceuticals/biologics
• Knowledge and actual experiences of interaction with the HAs in Japan, such as consultation meeting and/or J-NDA review
• Understanding of the trend and changing regulatory environment surrounding clinical trials in Japan and global. Familiarity with CTD format and ICH requirements for J-NDA filing and clinical development
• Ability to strategically apply knowledge across a portfolio of products
• Good leadership, project management and communication skills as well as managerial capability
• Self-learning & Multi-tasking capabilities
• English both spoken and written – business level required

Make a difference with Teva Pharmaceuticals

Please submit your CV and a Cover Letter.
Please note that only shortlisted candidates will be contacted.

Reports To

Head of Innovative Medicines Regulatory Affairs in Japan

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.