Job Description

WHAT YOU WILL DO

Let’s do this. Let’s change the world. In this vital role, you will lead the Global Regulatory Operations team in support of regulatory submissions and management of regulatory information worldwide. Engage on cross-functional teams to provide a strategy for the development and implementation of initiatives to improve processes and information/data quality and management

RESPONSIBILITIES INCLUDE:

Provide strategic leadership of Regulatory Operations core functions including Submissions Management & Publishing, Process & Systems Excellence, RIM, Data Quality & Analytics and Compliance including XEVMPD/IDMP
Provide Regulatory Operations strategy to teams including dossier publishing, lifecycle maintenance, data exchange, and archival
Ensure compliance with international data standards to ensure compliance with Health Authority regulations for submissions and registrations
Collaborate with cross-functionally internally and externally to GRAAS to ensure Regulatory Operations business needs are met
Act as Business Process Owner for Regulatory Operations business processes/initiatives; Collaborate with other BPOs to resolve cross-functional challenges
Lead strategy, implementation, and organizational change management related to new and existing Regulatory Operations processes, tools, and data across R&D
Partner with DTI to develop and drive the multi-year roadmap for Regulatory Operations to increase speed, quality/compliance, and efficiency
Drive and advance Regulatory Operations strategy to ensure usability, efficient data entry, quality, integration, and analytics
Ensure effective Governance, Support and Change Management, and secure user consensus and adoption to ensure GRAAS captures the value/ROI of Regulatory Operations investments
Build and leverage relationships with industry, vendor, and trade associations to influence future regulatory environment from a regulatory operations perspective
Partner with Global Process Networks to ensure connectivity and continuous process improvement in cross-functional E2E processes
Partner with Regulatory Operations partners/suppliers to influence future roadmaps to ensure ongoing successful and compliant support

KEY SKILLS AND KNOWLEDGE:

Submissions and regulatory information management processes, tools/applications, governance, and support
Drug registration procedures and dossier requirements worldwide
Team Leadership, Coaching, and Mentoring
Negotiation, Collaboration, and Persuasion
Strong understanding of the impact of emerging regulatory registration requirements and their implications for Amgen
Anticipating and resolving problems; critical thinking
Communications and relationship building
Customer-centric
Strong knowledge of and vision for Regulatory Operations processes and document/data management
Demonstrated excellence in project and change management and stakeholder engagement
Inform, influence, and pivot based on stakeholder insight
Identify and effectively communicate options, risks and mitigations and escalate risk judiciously