Director, Technology – Global Regulatory Operations (GRAAS)

Career Category

Job Description

Join Amgens Mission of Serving Patients

At Amgen if you feel like youre part of something bigger its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980 weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology Inflammation General Medicine and Rare Disease we reach millions of patients each year. As a member of the Amgen team youll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives.

Our award-winning culture is collaborative innovative and science based. If you have a passion for challenges and the opportunities that lay within them youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director Technology-Global Regulatory Operations

What you will do

Lets do this. Lets change the this vital role you will lead the end-to-end digital strategy delivery and operational excellence of Global Regulatory Affairs and Safety (GRAAS) systems. This role will provide strategic oversight of the capabilities provided by platforms such as Veeva Vault RIM Lorenz DocuBridge and TrialScope while driving transformational initiatives that improve regulatory operations data quality and compliance across all regions and product lifecycles.

The successful candidate will operate at the intersection of technology compliance and business processpartnering with senior regulatory leaders technology partners and external vendors to ensure global systems deliver business value innovation and inspection readiness.

Strategic Leadership & Program Ownership

• Lead the global digital strategy and roadmap for regulatory operations across domains such as RIM CMC/device labeling publishing disclosure and Promotional Materials compliance.

• Own the lifecycle of regulatory systems from platform selection through implementation validation operations and sunsetting.

• Champion digital transformation initiatives including automation data-driven reporting and the adoption of cloud/AI capabilities to improve submission efficiency and regulatory data management.

• Represent GRAAS IS in audits inspections and compliance forums; ensure system audit readiness and alignment with GxP 21 CFR Part 11 and Amgens internal validation policies.

Business Engagement & Customer Partnership

• Collaborate with regulatory business leaders across Oncology General Medicine CMC Device EU-ICON JAPAC R&D Policy and Promotional Compliance to ensure systems meet evolving global needs.

• Serve as a trusted advisor and change agent helping business teams align digital investments with strategic regulatory objectives.

• Influence product roadmaps of internal/external vendors and represent Amgen in industry consortia (e.g. Accumulus TransCelerate).

Operational Excellence & Technical Oversight

• Lead and develop a team of IS professionals managing regulatory systems and services.

• Oversee system validation configuration management access controls and end-user support aligned with ITIL and GAMP 5 frameworks.

• Ensure proactive vendor governance including contract negotiation SLA enforcement and upgrade planning with partners such as Veeva Lorenz and TrialScope.

• Utilize SAFe Agile practices to manage enhancements change controls testing release management and user training.

Must Have Skills:

• Proven experience managing and supporting regulatory information management and submission systems with hands-on expertise in platforms like Veeva Vault RIM and eCTD publishing tools - Lorenz DocuBridge

• Experience with clinical trial disclosure systems such as TrialScope and TrialAssure

• Deep knowledge of FDA 21 CFR Part 11 GxP validation and regulatory system compliance best practices

• Experience running multi-region regulatory operations platforms (e.g. PMDA EMA FDA Health Canada)

• Proven leadership and team management skills in cross-functional matrixed environments with effective project coordination and on-time delivery.

• Expertise in collaborating with business stakeholders and external vendors including contract negotiation and performance oversight.

• Hands-on experience with computer system validation processes and documentation including knowledge of frameworks such as GAMP 5 and ITIL service management for high system reliability and compliance.

• Strong problem-solving and analytical abilities to translate business needs into technical solutions.

• Excellent communication skills able to clearly convey sophisticated information to both technical and non-technical audiences.

• Familiarity with IT infrastructure security principles and data governance in regulated environments.

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of enterprise SaaS/platform engineering or IT product leadership; at least 5 years in regulated life science or healthcare industry experience

Or

Masters degree and 7 years of enterprise SaaS/platform engineering or IT product leadership; at least 5 years in regulated life science or healthcare industry experience

Or

Bachelors degree and 9 years of enterprise SaaS/platform engineering or IT product leadership; at least 5 years in regulated life science or healthcare industry experience

Preferred Qualifications:

Good-to-Have Skills

• Veeva Vault Admin Certification or experience with configuration

• SAFe Agilist and change management certifications

• Knowledge of IDMP eCTD and future submission data standards

• Experience in master data governance and regulatory data quality programs

• Familiarity with tools like PleaseReview FileMaker Pro ISIToolbox EnFocus PitStop

Soft Skills & Leadership Traits

• Strategic thinker with the ability to convert vision into execution plans and measurable outcomes

• Strong communication and presentation skills with confidence interacting with senior stakeholders

• Collaborative leader skilled in cross-functional influence and virtual team management

• Comfortable operating across time zones with a global attitude and adaptability

What you can expect of us

As 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 well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to relevant skills experience and qualifications.

In addition to the base salary Amgen offers a Total Rewards Plan based on eligibility comprising of health and welfare plans for staff and eligible dependents financial plans with opportunities to save towards retirement or other goals work/life balance and career development opportunities that may include:

• A comprehensive employee benefits package including a Retirement and Savings Plan with generous company contributions group medical dental and vision coverage life and disability insurance and flexible spending accounts

• A discretionary annual bonus program or for field sales representatives a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Apply now and make a lasting impact with the Amgen team.

In any materials you submit you may redact or remove age-identifying information such as age date of birth or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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