The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Amgen Inc.; Global Patient Safety Product Manager; Thousand Oaks, CA. Provide strategic oversight for Global Patient Safety processes and technical document deliverables. PREPARING SUBMISSION-READY COMPONENTS FROM INTERNAL CONTRIBUTORS ACCORDING TO REGIONAL REGULATORY GUIDANCE RELYING ON REGULATORY- COMMITMENT DATABASE, APPIAN, LIQUENT, AND MICROSOFT SHAREPOINT; LIAISING BETWEEN THERAPEUTIC AREA TEAMS AND BUSINESS PROCESS OWNERS TO ENSURE ALIGNMENT OF GLOBAL REGULATORY AND SAFETY PLANS WITHIN SIGNAL MANAGEMENT, RISK MANAGEMENT, PERIODIC REPORTS, LABELING, GLOBAL REGULATORY AFFAIRS, AND COMMERCIALIZATION; CREATING AND SUBMITTING REGULATORY DOSSIERS ACCORDING TO FDA REQUIREMENTS, AND ECTD GUIDANCE AND SPECIFICATIONS; DEVELOPING AND TRACKING MULTIPLE THERAPEUTIC PRODUCT PROJECT TIMELINES FOR CROSS-FUNCTIONAL DELIVERABLES WITHIN GLOBAL REGULATORY AFFAIRS AND SAFETY; AND DEMONSTRATING KNOWLEDGE OF REGULATORY SUBMISSION DOCUMENT STANDARDS, INCLUDING REGULATORY COMPLIANT DOCUMENTS, INTERDEPENDENCY BETWEEN REGULATORY SUBMISSION DOCUMENTS THROUGHOUT PRODUCT LIFECYCLE. Interested candidates mail resume to: HR Connect c/o TM Review @ Amgen Inc. 2202 N Westshore Blvd., Suite 650, Tampa, FL 33607 Attn. Job #20516.621