Associate Director, Regulatory Affairs

Sumitomo Pharma Associate Director, Regulatory Affairs Honolulu, Hawaii Apply Now

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Regulatory Affairs. The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as a Regional Regulatory Leader (RRL) and is responsible for ensuring the execution of regional regulatory strategy in line with the global registration strategy of a project in collaboration with the Global Regulatory Leader (GRL). He/she is expected to provide regulatory support from proof of concept (PoC), development, registration, and post-approval for projects within the company’s portfolio.

Job Duties and Responsibilities

1. Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
2. Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL.
3. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments, briefing book for FDA meetings) and responses to HA information requests.
4. Represent GRA on less complex project related meetings and provide regulatory input as appropriate.
5. Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
6. Lead the documentation of regulatory interactions including decisions and outcomes.
7. Provide updates at the GRT meetings and project teams as needed.
8. Collaborate effectively with Regulatory Operations Leader (ROL).
9. Maintain professional working relationship with colleagues, fostering collaboration and idea sharing.
10. Review nonclinical, clinical and CMC documentation and contribute to content as needed.
11. Advise team members of major regulatory issues and provide possible solutions, and lead the mitigation strategy.
12. Ensure quality and content of submissions to Health Authorities.
13. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising and promotion.
14. Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives, Health Authority regulations, ICH guidelines, and company policies.

Education and Experience

Doctorate preferred (Pharm.D., Ph.D., M.D., etc.). Master’s degree required (preferably in a scientific discipline). 6 – 8 years relevant experience in biotech or pharmaceutical industry with a minimum of 6 years focused in Regulatory Affairs.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, gender identity or expression, affectional or sexual orientation, disability, veteran or military status, or any other characteristic protected by law.

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