Let’s do this. Let’s 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.
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 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
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:
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)
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.
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.
for a career that defies imagination
Objects in your future are closer than they appear. Join us.