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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.

Global Regulatory Operations Manager - Submission Management

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will 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.

• Supports or leads the tactical execution and detailed deliverables to support a Global Regulatory Filing within a regional/multi-regional filing plan.
• Lead the functional areas of the department and outsourced resources
• Take part in the career and skills development of staff members
• Ensure procedures are in place and followed for the processing of incoming and outgoing regulatory documentation from a publishing perspective
• Lead the preparation of submission ready components from internal contributors according to regional regulatory guidance and internal standards
• Lead the creation and submission of regulatory dossiers across regions according to local requirements and agreed upon timelines
• Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers
• Contribute to the development of the strategy for communicating with global health authorities
• 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 from a publishing perspective
• Develop and report publishing metrics to senior management
• Provide technical support for regulatory systems

Win

What we expect of you

We are all different, yet we all use our outstanding contributions to serve patients. The professional we seek is a leader with these qualifications.

• Experience working in and leading teams
• Knowledge of the industry and business principles for a regulatory operations department
• Maintaining relationships with contributing functions and affiliates
• Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications
• Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications
• Strong project management skills specifically related to regulatory projects
• Expert knowledge of eCTD, eCTD Specifications and eCTD software
• Expert knowledge of Emerging Markets Marketing Application submission requirements, country specifications, and software used
• Expert knowledge of International Clinical Trial and Paediatric submission requirements, country specifications, and software used
• Expertise in MS Word, Adobe Acrobat and a variety of Acrobat related plug-ins specific to regulatory publishing

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, improve your expertise, and increase your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Education & Experience

• Doctorate 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 Experience

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

Apply now

for a career that defies imagination

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

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