Sumitomo Pharma Associate Director, Regulatory Affairs Lincoln, Nebraska Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. For more information on SMPA, visit our website here or follow us on LinkedIn.
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
Manage regional regulatory activities as part of a Global Regulatory Team (GRT).
Ensure execution of regional regulatory plans in line with the global registration strategy.
Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports).
Represent GRA in project-related meetings and provide regulatory input.
Assess and communicate regulatory requirements ensuring compliance with regulations.
Document regulatory interactions including decisions and outcomes.
Collaborate effectively with Regulatory Operations Leader (ROL).
Review nonclinical, clinical and CMC documentation.
Advise team members of major regulatory issues and provide possible solutions.
Participate in the promotional materials review committee.
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.
Key Core Competencies
Strong verbal and written communication skills.
Ability to work in a diverse environment.
Experience contributing to electronic regulatory submissions.
Solid understanding of medical terminology, FDA and ICH regulations.
Experience interacting with the FDA.
Compensation and Benefits
The base salary range for this role is $153,700 to $192,100, along with opportunities for merit-based salary increases and a robust benefits package.
Equal Employment Opportunity
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer.
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