Associate Director, Regulatory Affairs

Sumitomo Pharma Associate Director, Regulatory Affairs Hartford, Connecticut 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 global regulatory leader (GRL).
3. Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures) and responses to HA information requests.
4. Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
5. Provide updates at the GRT meetings and project teams as needed.
6. Review nonclinical, clinical and CMC documentation and contribute to content as needed.
7. Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research.

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 minimum of 6 years focused in Regulatory Affairs.

Compensation and Benefits

The base salary range for this role is $153,700 to $192,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state.

Equal Employment Opportunity

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer.

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