Sumitomo Pharma
Director, Regulatory Affairs
Sumitomo Pharma, Boise, Idaho, United States, 83708
Sumitomo Pharma Director, Regulatory Affairs Boise, Idaho 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. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This position may train/mentor junior staff.
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
Leads and coordinates project team members in developing strategy for applicable documents/activities.
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions including decisions and outcomes
Provides updates at the Global Regulatory Team meetings and project teams as needed
Collaborates effectively with regulatory operations leader (ROL)
Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
Reviews nonclinical, clinical and CMC documentation and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
Ensures the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings, liaison with local Health Authority
Document owner of briefing book documentation to Health Authorities
Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes
Provide updates to the GRT, project teams, and governance boards as needed
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.
Key Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
Demonstrated ability to facilitate appropriate team decisions
Experience contributing to electronic regulatory submissions and working with regulatory templates
Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
Proven success/major involvement in NDA/MAA/CTD submissions and approval
Ability to make complex decisions and willingness to defend difficult positions.
Comfortable presenting to all levels of the organization including Senior Management.
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).
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.
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.
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, domestic partnership or civil union status; sex, gender, gender identity or expression; 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 or any other characteristic protected by law.
#J-18808-Ljbffr
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. This position is also responsible for providing internal expertise on FDA regulations governing the promotion and advertising of assigned products. This position may train/mentor junior staff.
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
Leads and coordinates project team members in developing strategy for applicable documents/activities.
Plans, coordinates, authors, and prepares regulatory submissions and works closely with Regulatory Operations in the electronic submission
Assesses and communicates regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines
Leads documentation of regulatory authority interactions including decisions and outcomes
Provides updates at the Global Regulatory Team meetings and project teams as needed
Collaborates effectively with regulatory operations leader (ROL)
Maintains professional working relationship with colleagues, fostering collaboration, and idea sharing
Reviews nonclinical, clinical and CMC documentation and contributes to content as needed
Advises team members of major regulatory issues and provides possible solutions and leads the mitigation strategy
Ensures the quality and content of all submissions to Health Authorities
Leads the regional health authority meetings, liaison with local Health Authority
Document owner of briefing book documentation to Health Authorities
Accountable in conjunction with the GRL for developing and maintaining the development core data sheet (DCDS) if required
Ensure compliance with global regulatory requirements and adherence to regulatory internal policies and processes
Provide updates to the GRT, project teams, and governance boards as needed
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.
Key Core Competencies
Strong verbal and written communication skills; interpersonal skills; listening skills; and organizational skills required
Unquestionable ethics, professional integrity, and personal values consistent with the SMPA values
Ability to work in a diverse environment
Demonstrated ability to adapt to changing priorities and work effectively in a matrix organization
Demonstrated ability to facilitate appropriate team decisions
Experience contributing to electronic regulatory submissions and working with regulatory templates
Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in the pharmaceutical industry
Proven success/major involvement in NDA/MAA/CTD submissions and approval
Ability to make complex decisions and willingness to defend difficult positions.
Comfortable presenting to all levels of the organization including Senior Management.
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).
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.
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.
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, domestic partnership or civil union status; sex, gender, gender identity or expression; 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 or any other characteristic protected by law.
#J-18808-Ljbffr