Sumitomo Pharma
Associate Director, Regulatory Affairs
Sumitomo Pharma, Atlanta, Georgia, United States, 30383
Sumitomo Pharma Associate Director, Regulatory Affairs Atlanta, Georgia 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. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director Regulatory Affairs is a member of the Regulatory Project team leading maintenance submissions to the IND / CTA / NDA, developing and maintaining project and content plans for complex submissions (IND / NDA) and overseeing Regulatory Operations activities including publishing, submitting and archiving of regulatory submissions and correspondence. Job Duties and Responsibilities Lead maintenance submissions to the IND / CTA / NDA. Leads preparation, coordination, authoring and monitoring of CTA / IND / NDA maintenance submissions (e.g., annual reports, investigator brochures, IND amendments). Attend project team meetings to provide input into regulatory requirements and company standards for IND / CTA / NDA maintenance submissions. Defines submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed to ensure submission readiness. Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. Facilitates submission preparation via completion of forms and creation of cover letters. Creates and maintains regulatory content and project plans and timelines for major submission projects (INDs, NDAs). Maintains project timelines and provides updates to senior management. Meets with authors/reviewers to monitor status of document creation and finalization as per project/content plan. Provides updates on dossier compilation to IND / NDA team. Overseeing the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions. Represents RA Oncology on project teams for matters relating to electronic (and paper) submissions as assigned. Advises and/or trains project teams on new requirements. Leads the training of appropriate R&D staff in the application of various standards and technologies. Other duties as assigned. Key Core Competencies Detail-oriented self-starter with excellent organizational, planning, and follow-up skills. Effective communication and presentation skills. Foundational strategic thinking and problem-solving skills. Ability to meet tight deadlines and juggle multiple priorities. Working across cultures in a diverse environment. Education and Experience Bachelor’s degree required; advanced degree preferred. 10+ years’ experience in the regulatory environment in the biotechnology/pharmaceutical industry. Experience in regulatory operations and/or regulatory submission management for global submissions. Experience working with vendors and clinical research organizations. Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW. Robust understanding of FDA and other health agency regulations and guidance governing submission content and format. Expert knowledge of regulatory electronic document management systems (Veeva). Prior project management experience with NDA/BLA submissions is required. Compensation and Benefits 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and a robust time-off policy including unlimited paid time off. 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. 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. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce.
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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. For more information on SMPA, visit our website
here
or follow us on
LinkedIn . Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director Regulatory Affairs. The Associate Director Regulatory Affairs is a member of the Regulatory Project team leading maintenance submissions to the IND / CTA / NDA, developing and maintaining project and content plans for complex submissions (IND / NDA) and overseeing Regulatory Operations activities including publishing, submitting and archiving of regulatory submissions and correspondence. Job Duties and Responsibilities Lead maintenance submissions to the IND / CTA / NDA. Leads preparation, coordination, authoring and monitoring of CTA / IND / NDA maintenance submissions (e.g., annual reports, investigator brochures, IND amendments). Attend project team meetings to provide input into regulatory requirements and company standards for IND / CTA / NDA maintenance submissions. Defines submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed to ensure submission readiness. Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. Facilitates submission preparation via completion of forms and creation of cover letters. Creates and maintains regulatory content and project plans and timelines for major submission projects (INDs, NDAs). Maintains project timelines and provides updates to senior management. Meets with authors/reviewers to monitor status of document creation and finalization as per project/content plan. Provides updates on dossier compilation to IND / NDA team. Overseeing the tracking, compiling, publishing, quality checking, dispatching and archiving of Health Authority submissions. Represents RA Oncology on project teams for matters relating to electronic (and paper) submissions as assigned. Advises and/or trains project teams on new requirements. Leads the training of appropriate R&D staff in the application of various standards and technologies. Other duties as assigned. Key Core Competencies Detail-oriented self-starter with excellent organizational, planning, and follow-up skills. Effective communication and presentation skills. Foundational strategic thinking and problem-solving skills. Ability to meet tight deadlines and juggle multiple priorities. Working across cultures in a diverse environment. Education and Experience Bachelor’s degree required; advanced degree preferred. 10+ years’ experience in the regulatory environment in the biotechnology/pharmaceutical industry. Experience in regulatory operations and/or regulatory submission management for global submissions. Experience working with vendors and clinical research organizations. Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW. Robust understanding of FDA and other health agency regulations and guidance governing submission content and format. Expert knowledge of regulatory electronic document management systems (Veeva). Prior project management experience with NDA/BLA submissions is required. Compensation and Benefits 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 merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances, and a robust time-off policy including unlimited paid time off. 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. 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. Mental/Physical Requirements : Fast-paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Sumitomo Pharma America (SMPA)
is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce.
#J-18808-Ljbffr