Director Regulatory Affairs, NB50272115 - Thousand Oaks, CA

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com We are seeking talented individuals to help bring our products to those in need.Role/Purpose:- Be the liaison between various Japan development teams and GRAAS-Japan- As an expert on Japan drug development, provide timely and accurate guidance to Amgen teams working on development programs and post-marketing support activities in Japan- Provide regulatory CMC expertise to GRAAS colleagues and Operations group- Provide expertise on clinical trial application process in Japan- To facilitate effective interactions between business partners or regulatory agency and Global Regulatory Affairs and Safety functions- To serve as a subject matter expert on Japanese regulatory requirements and conventions regarding pharmaceutical affairs and drug safety in support of various governance bodies Amgen staff and senior management in Regulatory Affairs and Safety- To ensure compliance and harmonization between Amgen’s and the Japanese partners’ establish appropriate SOPs and BP- Keep abreast of key regulatory policies that would impact drug development in JapanKey responsibilities include:- In collaboration with Amgen’s global functions, be accountable for accurate and timely regulatory information to the Japan project teams- Liaise and support regulatory affairs and safety interactions with business partners and regulatory agency in accordance with local regulations (e.g., GCP, GMP, GVP) and conventions in Japan- Partner with strategic sourcing for selection of appropriate vendors and CROs in Japan- Be aware of up-to-date local intelligence (current state and future trends) in regulatory, AER, pharmacovigilance and post-market surveillance in Japan, directly or through external consultants- Evaluate and provide guidance to Amgen teams regarding regulatory and safety issues related to Amgen products in Japan that may have global impact- Provide regulatory affairs and safety expertise support to the Operations (Manufacturing and Quality) and Clinical Development groups at Amgen- Bachelors (pharmaceutical science preferred) plus 8-10 years of biotech/pharmaceutical experience in the areas of drug development - Experience with Japanese drug development and knowledge of Japanese regulatory environmentPreferred Qualifications:- Master’s or doctoral degree in pharmaceutical science or related field plus 8 years of biotech/pharmaceutical experience- Experience with biopharmaceutical industry in Japan- Broad experience or drug development, new drug application processed and clinical trials- Strong communication and project management skills- Previous management experience and ability to manage staff remotely- Spoken and written Japanese Amgen is the leading human therapeutics company in the biotechnology industry. Our mission is to serve patients. We foster a culture of innovation, using our expertise in advanced science and technology to find new and better medicines to fight serious illness. For more information about Amgen, our visionary science, and our powerful medicines, visit: www.amgen.com Company: Amgen Inc. Location: Thousand Oaks, CA 91362 Job Category: Business/Strategic Management Reference Code: 50272115