Job Description

Career Category Regulatory



HOW MIGHT YOU DEFY IMAGINATION?

At Amgen, every challenge is an opportunity. And every opportunity brings the potential to change lives. Our shared mission-to serve patients-has driven our status as one of the world\xe2\x80\x99s preeminent biotechnology companies, reaching over 10 million patients worldwide. Leverage your high expertise to lead and forge partnerships that advance the biotechnical and biopharmaceutical science that can turn the tide of serious, life-interrupting illnesses.

Vice President, Regulatory Affairs, JAPAC

Live

What will you do

Let\xe2\x80\x99s do this. Let\xe2\x80\x99s change the world. In this vital role, as the Vice President, Regulatory Affairs, Japan & Asia Pacific (JAPAC), spanning both the regional hub and local affiliate organizations, you are a member of the Global Executive Leadership Team (ELT) for Global Regulatory Affairs and Strategy (GRAAS) and the JAPAC Regional Leadership Team (JLT).

The purpose of this role is to provide leadership of the Regulatory Affairs organization in the JAPAC region, and to ensure the development and execution of robust regulatory strategies and execution of filing plans leading to the successful approval of competitive products in the region. The Regional Regulatory Affairs Lead will build and maintain both internal and external executive-level relationships including but not limited to key regulatory agencies, trade associations and other external forums.

Responsibilities

Strategy and Execution

Leadership and high-level oversight and advice to the leader(s) of Regional and Local regulatory filing teams in the preparation of robust regulatory strategies for the JAPAC region.

Guide the Global and Regional regulatory filing teams, spanning both pipeline and marketed products, to develop successful regulatory strategies for initial registration and life-cycle management in the JAPAC region.

Provide regulatory Subject Matter Expertise to product teams relating to the Commercialization of Amgen\xe2\x80\x99s assets in JAPAC.

Provide advice to GRAAS and R&D leadership on opportunities to deliver more efficient regulatory strategies in the JAPAC region.

External Interactions

Participate in, and represent Amgen in key external forums, (e.g., Trade Associations and strategic working groups) in JAPAC.

Act as the Amgen Regulatory spokesperson in the JAPAC trade press and other media on regulatory issues and developing legislation / processes.

Develop and maintain executive-level relationships with JAPAC regulatory stakeholders (eg. PMDA leadership, NMPA leadership, etc.).

Functional Leadership

Leadership of an integrated regulatory strategy and regulatory affiliate organization in JAPAC.

Leadership of JAPAC Regulatory Affairs and escalation/cascade both to and from GRAAS ELT.

Ensure a highly engaged, motivated and informed staff in JAPAC Regulatory Affairs both at the regional hub and local affiliate level. Effectively manage organization headcount and budget within the terms of the Amgen Operating Model, collaborating closely with Commercial partners.

Lead and drive effective prioritization of key regulatory deliverables and the focus / allocation of JAPAC regulatory staff and resources.

Provide matrix leadership of JAPAC regulatory CMC and Policy organizations.

Ensure best in class LMS compliance and governance.

Represent the ongoing regulatory status and regulatory strategies of all pipelines and marketed products in the Amgen portfolio to the JAPAC Executive Team.

Represent the JAPAC Regulatory Affairs organization at the GRAAS ELT.

Co-leadership of OCMO Forum and act as an ongoing leadership role model for close collaboration and communication across R&D functions in JAPAC.

Represent JAPAC Regulatory Affairs in appropriate governance and advisory forums (e.g., GRAC).

Forge and maintain effective collaborations with key Control Functions both within R&D (e.g., Global Patient safety) and cross functional partners (e.g., Global Value & Access)

Serve as a role model for JAPAC R&D leaders and staff with internal and external teams (opinion leaders, investigators and relevant agencies)

Build JAPAC development organizations to desired future capabilities \xe2\x80\x93 taking accountability for selected regional studies, regional study conduct in global studies and JAPAC regulatory correspondence and findings, dependent upon program and molecule

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Vice President of JAPAC Regulatory Affairs we seek is an experienced leader with the following qualifications. They will also embody the Amgen leadership attributes which are:

Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive

Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection

Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders

Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results

Basic Qualifications

Doctorate degree & 8 years of Regulatory & Compliance experience OR

Master\xe2\x80\x99s degree & 10 years of Regulatory & Compliance experience OR

Bachelor\xe2\x80\x99s degree & 12 years of Regulatory & Compliance experience AND

8 years of direct managerial experience, previous experience managing other managers

Preferred Qualifications

Relevant degree in science or related discipline, ideally with Masters, PhD. or M.D.

Expert in JAPAC regulatory agency interactions/ strategy, regulation, guidance and legislation (specifically China and/or Japan).

Proven track record of high-level relationships with key Health Authorities and stakeholders.

Deep knowledge of drug development (Nonclinical, clinical and CMC aspects).

Substantial depth of understanding of JAPAC regulatory authority operations and submission process.

Comprehensive understanding of regulatory activities and how they affect drug development projects and processes.

Significant breadth and depth of leadership experience with demonstrated ability to lead large and geographically dispersed teams.

Skilled in influencing and managing stakeholders across a complex matrix, particularly relationships with country General Managers.

Demonstrable ability to set organizational direction & champion change and continuous improvement.

Proven ability to anticipate and mitigate against future strategic issues & uncertainties.

Ability to resolve conflicts and develop a course of action leading to a beneficial outcome.

Cultural awareness and sensitivity to achieve results across both regional country and international borders.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates\xe2\x80\x99 professional and personal growth and well-being.

In addition to the base salary, Amgen offers a generous Total Rewards Plan comprising health, finance & wealth plans for staff and eligible dependents with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities.

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.

Competitive base pay and opportunities for annual performance bonus awards

Stock-based long-term incentives (GCF level 6 & above)

Award-winning annual leave plans and Early Release for Eve of 4 major festive holidays

Flexible work models, including remote work arrangements, where possible

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Amgen