Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Cheyenne, Wyoming, United States, 82007
Sumitomo Pharma Associate Director, Regulatory Affairs Cheyenne, Wyoming 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.
This position has a moderate-high level of autonomy but may require some coaching and mentoring.
Job Duties and Responsibilities
Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL.
Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments) and responses to HA information requests.
Represent GRA on less complex project-related meetings and provide regulatory input as appropriate.
Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
Lead the documentation of regulatory interactions including decisions and outcomes.
Provide updates at the GRT meetings and project teams as needed.
Collaborate effectively with Regulatory Operations Leader (ROL).
Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.
Review nonclinical, clinical and CMC documentation and contribute to content as needed.
Advise team members of major regulatory issues and provide possible solutions.
Lead and coordinate local project team members in developing strategy for applicable documents/activities.
Ensure quality and content of submissions to Health Authorities.
Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals.
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 coordinate regulatory compliance activities at a global level.
Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research.
Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives.
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, 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.
Experience contributing to electronic regulatory submissions.
Solid understanding of medical terminology, and FDA and ICH regulations/guidances.
Experience reviewing nonclinical, clinical and CMC documentation.
Experience interacting with the FDA.
Experience in successfully leading teams.
Ability to learn new therapeutic areas when necessary.
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.
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.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer .
#J-18808-Ljbffr
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.
This position has a moderate-high level of autonomy but may require some coaching and mentoring.
Job Duties and Responsibilities
Manage regional (United States and/or European) regulatory activities as part of a Global Regulatory Team (GRT).
Ensure execution of regional regulatory plans in line with the global registration strategy in collaboration with the GRL.
Lead preparation, coordination, authoring and monitoring of submissions (e.g., IND/NDA submissions, annual reports, investigator brochures, IND amendments) and responses to HA information requests.
Represent GRA on less complex project-related meetings and provide regulatory input as appropriate.
Assess and communicate regulatory requirements ensuring activities are in compliance with applicable regulations and guidelines.
Lead the documentation of regulatory interactions including decisions and outcomes.
Provide updates at the GRT meetings and project teams as needed.
Collaborate effectively with Regulatory Operations Leader (ROL).
Maintain professional working relationships with colleagues, fostering collaboration and idea sharing.
Review nonclinical, clinical and CMC documentation and contribute to content as needed.
Advise team members of major regulatory issues and provide possible solutions.
Lead and coordinate local project team members in developing strategy for applicable documents/activities.
Ensure quality and content of submissions to Health Authorities.
Assist with development of the global regulatory functional plan through the research, review and interpretation of related product approvals.
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 coordinate regulatory compliance activities at a global level.
Participate in the promotional materials review committee (PMRC) along with Marketing Brand Teams, Legal, Medical Affairs and Clinical Research.
Conduct regulatory review of promotional and non-promotional materials in accordance with business goals and objectives.
Key Core Competencies
Strong verbal and written communication, interpersonal, listening, 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.
Experience contributing to electronic regulatory submissions.
Solid understanding of medical terminology, and FDA and ICH regulations/guidances.
Experience reviewing nonclinical, clinical and CMC documentation.
Experience interacting with the FDA.
Experience in successfully leading teams.
Ability to learn new therapeutic areas when necessary.
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.
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.
Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer .
#J-18808-Ljbffr