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. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( . **Job Overview** We are currently seeking a dynamic, highly motivated, and experienced individual for the position of **Senior Manager, Regulatory Affairs** . The Senior Manager is part of the Global Regulatory Affairs (GRA) team based in the US and he/she will primarily function as a regional regulatory leader (RRL) and support the global regulatory leader (GRL) as requested. This position is responsible for the preparation, coordination and monitoring of routine US regulatory submissions and responses to health authority (HA) information requests. This position represents GRA on less complex project related meetings and provides regulatory input as appropriate. This position works with a moderate level of independence and autonomy and requires some coaching and mentoring. **Job Duties and Responsibilities** + Manage regional (United States) regulatory activities as part of the Global Regulatory Team (GRT) + Supports the global regulatory lead (GRL) and the CMC regulatory lead in the formulation of regulatory strategy, and interactions with HAs + Leads the preparation, coordination and monitoring of routine US regulatory submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments including CMC, briefing book for FDA meetings) and responses to HA information requests + Leads the preparation, coordination and monitoring of worldwide regulatory submissions related to clinical trials and responses to HA information requests + Reviews nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator brochures, CMC information/data) and contributes to content as needed + Competently and confidently represents GRA on less complex project related meetings and provides regulatory input as appropriate + Assess and communicate regulatory requirements, ensuring activities are in compliance with applicable regulations and guidelines + Contributes to the documentation of regulatory interactions including decisions and outcomes + Provides updates at the GRT meetings upon request + Effective collaboration with regulatory operations leader (ROL) + Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing **Key Core Competencies** + Ability to work in a diverse environment + Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills are required + Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization + Demonstrated ability to facilitate appropriate team decisions + Sense of urgency and perseverance to achieve results + Understands issues, problems and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop appropriate solutions. **Education and Experience** + B.S. degree, preferably in a scientific discipline + 4 years of experience, prior biopharmaceutical or pharmaceutical industry experience; Ideally with a minimum of 4 years focused in regulatory affairs + Experience contributing to electronic regulatory submissions and working with regulatory templates + Solid understanding and familiarity with medical terminology, and FDA and ICH regulations/ guidance specific to clinical research, CMC and general product development in the pharmaceutical industry + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to clinical trials is a plus + Experience in working with clinical research organizations The base salary range for this role is $156,560 to $195,700 . 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. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. 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. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ( or follow us on LinkedIn ( . At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_
Job ID: 474689296
Originally Posted on: 4/25/2025
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