Job Description This role will work on one of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory agencies receive timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the companys growth, thereby accomplishing corporate goals. This is a remote role that is required to work EST hours. A candidate in the Eastern Time Zone is preferred but not required. Responsibilities:  Develop and implement US regulatory strategy for assigned project(s). Strategize and plan for FDA meetings.  Serve as the primary contact with FDA and liaise, negotiate and orchestrate meetings and teleconferences with FDA  Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications.  Participate in global project team meetings (development and/or marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.  May serve as the single regulatory representative on study teams  Review and interpret regulatory guidelines. We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .     To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements 10+ years in the pharmaceutical industry. 8+ years in regulatory affairs. Experience in providing regulatory strategic input into the drug development process with thorough knowledge of the IND and NDA/BLA processes. In depth knowledge of oncology and associated RA strategy Experience acting as primary point of contact with the FDA BS degree in chemistry, biology or other related scientific discipline required. Masters, PhD or PharmD Masters, PhD, or PharmD null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to HR@insightglobal.com.