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Help maintain relationships with regulatory bodies in the states where Oscar operates.Develop a repository of internal procedural guides on reporting obligations to support teams and retain institutio...
The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Glob...
Propose and design well-informed global regulatory strategies for drug product applications and drug product promotional material. Represent Regulatory Affairs on review of promotional materials and p...
• Provide leadership and direction for regulatory activities, including input into clinical development plans, protocol design, and assessment of study results to meet regulatory and scientific obj...
Cultivate an effective system for ensuring that relevant legislative, regulatory, enforcement and administrative developments and trends are reviewed promptly, analyzed carefully, and communicated to...
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents...
Strong knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends, making recommendations to senior management to drive proactive initi...
Provides oversight and direction to the company regarding content and clarity of information presented in regulatory submissions, ensuring timely preparation of organized and scientifically valid appl...
Coordinate and maintain the tracking and reviewing of regulatory submissions including annual reports, IND applications, informed consent forms, protocol reviews and review for accuracy and completene...
Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities. Build long term effective relationships and open communica...
Advise and provide regulatory subject matter expertise support to business partners. Apply knowledge and expertise to maintain compliance with applicable regulations and to develop, plan coordinate an...
Responsible for all aspects of regulatory submissions, including IND, BLA, ANDA, NDA and major Supplements in electronic format per the eCTD requirements, etc. Serves as an internal expert on FDA regu...
Responsible for the identification, approval and evolution of compliant, efficient and relevant regulatory services and systems, including system upgrades; best-practice process improvements; and regu...
Manage development of State acceptable labels and ensure compliance w/ state regulations by working with business teams and label specialists during the label development and submission process (feder...