Associate Director, Regulatory Affairs

Sumitomo Pharma Associate Director, Regulatory Affairs Annapolis , Maryland 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 regulatory activities as part of a Global Regulatory Team (GRT).
2. Ensure execution of regional regulatory plans in line with the global registration strategy.
3. Lead preparation, coordination, authoring and monitoring of submissions and responses to health authority information requests.
4. Assess and communicate regulatory requirements ensuring compliance with applicable regulations and guidelines.
5. Provide updates at the GRT meetings and project teams as needed.
6. Collaborate effectively with Regulatory Operations Leader (ROL).
7. Review nonclinical, clinical and CMC documentation and contribute to content as needed.
8. Participate in the promotional materials review committee (PMRC).

Key Core Competencies

1. Strong verbal and written communication, interpersonal, listening, and organizational skills.
2. Unquestionable ethics and professional integrity.
3. Ability to work in a diverse environment and adapt to changing priorities.
4. Experience contributing to electronic regulatory submissions.
5. Solid understanding of medical terminology, and FDA and ICH regulations.

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.

Compensation

The base salary range for this role is $153,700 to $192,100, including a total rewards package.

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

Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. 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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