GRAAS Operations Manager-Submission Manager - Americas

Lets do this. Lets change the world. In this vital role you will help ensure the smooth compliant flow of information between all functional areas, internal and external to GRAAS, including local offices, external partners and regulatory authorities within the North American context. This role leads the creation of regulatory submissions through detailed planning and delivery of regulatory submission components and product dossiers, bringing strategic technical expertise to drive operational excellence, innovation and ensured technical compliance of Amgen's global regulatory submissions. The ideal candidate will have a strong background in international submission management, regulatory affairs, and people management.




Roles & Responsibilities:

Manage various Clinical Trial and Marketing Application 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 Amgens 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

Masters degree and 4 to 6 years of directly related experience OR

Bachelors 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, well 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.



Apply now

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