HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? 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, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Global Submission Management - Manager

What you will do

Ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities. Bring strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions.

Job Summary

Supports or leads the tactical execution and detailed deliverables to support a Global Regulatory Filing within a regional/multi-regional filing plan.

Key Activities

• Lead the functional areas of the department and outsourced resources
• Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
• Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
• Represent departmental expertise on global work streams
• Initiate, lead and manage process development and improvement
• Lead information system and software update projects as well as ongoing system validations
• Develop and report publishing metrics to senior management
• Provide technical support for regulatory systems

Knowledge and Skills

• Experience working in and leading teams
• Knowledge of the industry and business principles for a regulatory operations department
• Proficient in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
• Strong project management skills specifically related to regulatory projects
• Expertise in eCTD, eCTD Specifications and eCTD software
• Expert knowledge of International Clinical Trial and submission requirements, country specifications, and software used

Basic Qualification

Doctorate degree

OR

Master’s degree and 3 years of directly related experience

OR

Bachelor’s degree and 5 years of directly related experience

OR

Associate’s degree and 10 years of directly related experience

Or

High school diploma / GED and 12 years of directly related experience

Preferred Qualifications

• Experience in a regulatory operations-focused role
• Experience liaising with global regulatory authorities as it pertains to regulatory submissions
• Expert knowledge in regional agency requirements for submissions
• Expertise with standard software utilized by regulatory publishing groups

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’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising 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 including:

• 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 and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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.