GRAAS Operations Manager-Submission Manager - International

plication type submissions and associated Global/Submission Content Plans

• Provide guidance to global cross-functional teams on dossier deployment strategies, submission timeline development and the structure of regional dossiers

• Serve as primary point of contact between Amgen's functional contributors and external partners, to ensure smooth delivery of regulatory submissions to identified agencies and subsequent archival in the appropriate system

• Independently remain current on guidance (internal/external) and translate requirements into operational activities

• Effectively represent global submission management expertise on key projects and global workstreams

• 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

• 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 metrics to senior management

• Provide technical support for regulatory systems

• Manage relationships with contributing functions and affiliates

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master's degree and 4 to 6 years of directly related experience OR

• Bachelor's degree and 6 to 8 years of directly related experience OR

• Diploma and 10 to 12 years of directly related experience

Preferred Qualifications:
Required Knowledge and Skills:

• Advanced technical and project management skills, demonstrated experience working in and leading teams

• Strong working knowledge of worldwide regulatory submissions in "electronic Common Technical Document" (eCTD) format, NeeS and paper, including, but not limited to original applications; amendments; supplements; periodic/annual reports; promotional materials; meeting packages; etc.

• Subject Matter Expert for the creation, maintenance and overall management of Global/Submission Content Plans, reports and dashboards

• Expertise in the submission and maintenance of global Clinical Trial and Marketing Applications

• Expert knowledge of Global, International and Emerging Markets Marketing Application submission requirements, country specifications, and software used

• Expert knowledge of eCTD, eCTD Specifications and eCTD software used by regulatory publishing groups (Lorenz docuBridge Explorer preferred)

Preferred Knowledge and Skills:

• Advanced knowledge of Veeva Vault RIM,

• Expertise in the regulations and regulatory guidance applicable to global Clinical Trial and Marketing Applications

• Strong project management skills specifically related to regulatory projects, and working across company disciplines (e.g., Clinical, Safety, CMC, Nonclinical, Labeling, Regulatory Strategy) to ensure timely delivery and operational execution of regional/multi-country submission filing plans.

• Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

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, we'll support your journey every step of the way.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
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