Share this Job

Sr Mgr Regulatory Affairs - 7198

Date: May 14, 2019

Location: Ebisu, JP, 1506018

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

Support the development and registration of new Specialty products. Provide input regarding RA strategy planning and execution, and support filing and maintenance activities to ensure submissions and responses to PMDA in timely manner and in compliance with the current regulatory requirements. The position requires proven RA knowledge and understanding of Japanese regulatory standards and requirements. Responsible for communication with the Global development teams and Global and Regional RA in cooperation with Head of Specialty RA JP.

・Support Head of Specialty RA with the planning, management and execution of the Regulatory Affairs activities in Japan, including PMDA consultation and J-NDA preparation and submission.

・Participate in the development of regulatory strategies for Japan.
・Schedule and manage Regulatory Affairs submission tasks, including pre-approval and post-approval activities, in coordination with global and Japan organization.
・Acquire understanding of Global development plan and Global dossier content for assigned products, identify gaps and propose mitigations to complete Japanese filing.
・Prepare and compile regulatory dossiers for PMDA consultation and J-NDA on track and filed in a timely manner.
・Support creation of labels and package inserts; provide regulatory information to the sites, Logistics, Finance, etc., to ensure correct and timely completion.
・Provide information on Japan-specific requirements to Global teams.
・Ensure submissions are in compliance with PMDA/MHLW current requirements.
・Assess emerging issues and develop solutions to address them with members of management and stakeholders, together with Head of Specialty RA JP.
・Upload submitted documentation to Teva’s document data base (GMRAR).
・Ensure online updating of Global Insight.
・Cooperate with and support external development partners to ensure on-time completion of activities.
・Monitor, anticipate, collect and interpret regulatory issues and trends that will impact the development of products for the Japanese market, incl. policies and procedures, share this information with appropriate regional functions and assist in the development of strategies and plans of action to address them.
・Ensure close collaboration with other relevant Global and Japan functions such as Medical, Pharmacovigilance, Marketing/Commercial, Portfolio and Quality.
・Participate in PMDA meetings/negotiations with PMDA, as required.
・Review and provide Regulatory Affairs sign-off of regulated documentation, where required.

Qualifications

・At least 5 years of experience in RA for new drug development (not operational RA) in foreign based global pharmaceutical company
・Proven working experience with foreign based global pharmaceutical companies in Japan is a mandatory
・In depth understanding of latest Regulatory law/guideline/requirement in Japan
・Understanding of Local regulatory environment and key initiatives
・Good communication skills; proficient in written and spoken English

Reports To

Director, Head of Specialty Regulatory Affairs, Japan

Teva’s Equal Employment Opportunity Commitment

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.