Director, Head of Regulatory Operations & Information Management, US – Remote

Director, Head of Regulatory Operations & Information Management, US
– Remote

If you feel like you’re part of something bigger, it’s because you are.

At Amgen, our shared mission—to serve patients—drives all that we do.

It is key to our becoming one of the world’s leading biotechnology companies.

We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide.

It’s time for a career you can be proud of.

Join us.

Director, Head of Regulatory Operations & Information Management

Live

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

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

The Regulatory professional we seek is a innovative leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of directly related experience OR Master’s degree and 8 years of directly related experience OR Bachelor’s degree and 10 years of directly related experience

Preferred qualifications:

• 10 years of experience directly managing people and successfully leading cross-functional Regulatory Operations teams, projects/programs
• Strong understanding of Regulatory Operations processes and systems including Regulatory Information Management & Document/ Data Management
• Strong people, communication, and matrix leadership skills
• Lean/Six Sigma or other process improvement methodologies

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt.

Join us.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives.