Job Description
Career CategorySafetyJob DescriptionLet’s do this. Let’s change the world. In this vital role you will lead a team, providing subject matter expertise, and collaborating with stakeholders to help drive innovation and efficiency in regulatory affairs. The Senior Manager will also be responsible for helping to deliver continuous improvement to enterprise regulatory systems, streamlining data models, and influencing vendor partnerships to ensure regulatory compliance and deliver measurable business results.Roles & Responsibilities:Leadership: Implement the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.Domain Expertise: Serve as an in-house domain expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.System Process Simplification: Find opportunities to simplify and streamline system-based processes and user interfacesTeam Leadership: Lead a team of experts responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs.Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirementsEnterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols.What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications. Basic Qualifications:• Doctorate degree and 2 years of regulatory systems experience OR• Master’s degree and 8 to 10 years of regulatory systems experience OR• Bachelor’s degree and 10 to 14 years of regulatory systems experience OR• Diploma and 14 to 18 years of regulatory systems experience Preferred Qualifications:Leadership: Implement the strategic roadmap for regulatory information systems, aligning technology initiatives with organizational goals and regulatory compliance requirements.Subject Matter Expertise: Serve as an in-house domain expert (SME) on regulatory information management, keeping abreast of evolving regulatory landscapes and technology trends.System Process Simplification: Find opportunities to simplify and streamline system-based processes and user interfacesTeam Leadership: Lead a team of experts responsible for the implementation, maintenance, and continuous improvement of regulatory information systems and data management processes.Vendor Management: Collaborate with external vendors and technology partners to optimize system capabilities and influence product roadmaps to meet organizational needs. Data Model Expertise: Serve as a data model expert with a focus on IDMP, ensuring that the organization's regulatory information aligns with evolving data standards and requirementsEnterprise User Base Support: Provide guidance, training, and support to a large user base, ensuring successful utilization of regulatory information systems.Compliance Assurance: Ensure that all regulatory information systems and adhere to relevant regulatory requirements, standards, and data security protocols. Preferred Knowledge and Skills:Advanced knowledge of Enterprise Information management systems such ERP, QMS, & Change Management, Familiarity with global regulatory requirements and standards beyond the organization's primary market.Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.Experience with regulatory documents in Regulatory Affairs, Research, Development, Quality Management, or related areaExperience in implementing large scale enterprise systems in the Biotech/Pharmaceutical industryWhat you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply nowfor a career that defies imaginationObjects in your future are closer than they appear. Join us.careers.amgen.com .
