Sumitomo Pharma
Director, Regulatory Affairs
Sumitomo Pharma, Bismarck, North Dakota, us, 58502
Sumitomo Pharma Director, Regulatory Affairs Bismarck, North Dakota 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
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company.
Job Duties and Responsibilities
Manage and Develop Talent
May train/mentor junior staff
As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
Leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
Competently represents GRA on project team meetings
Plans, coordinates, authors, and prepares regulatory submissions
Assesses and communicates regulatory requirements ensuring compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions
Provides updates at the Global Regulatory Team meetings and project teams
Collaborates effectively with regulatory operations leader (ROL)
Maintains professional working relationship with colleagues
Reviews nonclinical, clinical and CMC documentation and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions
Ensures the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings
Assist with development of the global regulatory functional plan
Accountable for developing and maintaining the development core data sheet (DCDS)
Ensure compliance with global regulatory requirements
Provide strategic review of dossier summaries, expert statements, and development management plans
Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Education and Experience
8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline).
Key Core Competencies
Strong verbal and written communication skills
Unquestionable ethics and professional integrity
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities
Experience contributing to electronic regulatory submissions
Advanced understanding of medical terminology, and FDA and ICH regulations
Proven success/major involvement in NDA/MAA/CTD submissions and approval
Ability to learn new therapeutic areas when necessary
Experience interacting with the FDA and ex-US Health Authorities
Compensation and Benefits
The base salary range for this role is $183,000 to $228,800. 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. 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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Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of
Director Regulatory Affairs . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the development and implementation of regulatory strategy from proof of concept, development, registration, and post-approval for projects within the portfolio of the company.
Job Duties and Responsibilities
Manage and Develop Talent
May train/mentor junior staff
As a Regional Regulatory Lead, manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT)
Leads regulatory activities for assigned project(s) in line with the global registration strategy of the product
Competently represents GRA on project team meetings
Plans, coordinates, authors, and prepares regulatory submissions
Assesses and communicates regulatory requirements ensuring compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions
Provides updates at the Global Regulatory Team meetings and project teams
Collaborates effectively with regulatory operations leader (ROL)
Maintains professional working relationship with colleagues
Reviews nonclinical, clinical and CMC documentation and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions
Ensures the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings
Assist with development of the global regulatory functional plan
Accountable for developing and maintaining the development core data sheet (DCDS)
Ensure compliance with global regulatory requirements
Provide strategic review of dossier summaries, expert statements, and development management plans
Leads Global Regulatory Team (GRT), oversees planning and execution of global regulatory activities and submissions
May be responsible for creating and reviewing SOPs and regulatory department operating procedures.
Education and Experience
8 – 12 years with Master’s of relevant experience in biotech or pharmaceutical industry with minimum of 8 years focused in regulatory affairs. Master’s degree required (preferably in a scientific discipline).
Key Core Competencies
Strong verbal and written communication skills
Unquestionable ethics and professional integrity
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities
Experience contributing to electronic regulatory submissions
Advanced understanding of medical terminology, and FDA and ICH regulations
Proven success/major involvement in NDA/MAA/CTD submissions and approval
Ability to learn new therapeutic areas when necessary
Experience interacting with the FDA and ex-US Health Authorities
Compensation and Benefits
The base salary range for this role is $183,000 to $228,800. 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. 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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