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Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises team on changes that could impact future...
For the therapeutic areas, manages all submission activities and oversees regulatory writing such as pre-IND, Orphan/breakthrough designations, Scientific Advice, End of Phase I/II and pre-BLA/MAA mee...
Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across the organization to obtain and/or provide information/data for regulatory submissions...
Manage and track queries from and commitments to health authorities, collaborate with subject matter experts to provide written responses to queries, and provide periodic status updates regarding unfu...
Review system generated reports and analytics used to identify and report suspicious orders,Assists distribution centers with responses to governmental inspections and any resulting violations, puniti...
• 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...
Serve as the designated program regulatory health authority contact. Represents the company by leading interactions with regulatory agencies during all stages of development, registration and commerci...
Creates and implements CMC regulatory strategies for CTA submissions and marketing applications. This role will have accountability for regulatory CMC as well as represents regulatory on key internal...
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...
Assure that regulatory strategies throughout life cycle of compounds are in alignment with Immunology portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access stra...
Provide CMC regulatory support and guidance for assigned projects and interface with R&D, Project Management, Manufacturing, Quality, and Regulatory colleagues, as well as third party laboratories, gl...