Let’s do this. Let’s change the world. In this vital role you will help shape and implement the strategic framework for regulatory submissions across the Americas markets. The role involves leading the Americas GSM team in AIN, engaging with GSIM leadership, vendor partners and cross-functional filing teams, in particular, International Regulatory Affairs teams. Demonstrating internal and external resources to support optimised submission management, this role will drive the development of accelerated filing execution within a regional/multi-regional filing context.
Manage and mentor an impactful AIN team responsible for Regulatory submission management to Americas markets.
Implement optimized resourcing strategies, demonstrating internal teams and external partners for submission-related activities in the AIN context.
Drive process improvements for submission tools, methodologies, and workflows.
Ensure staff understanding and adherence to global and regional regulatory guidelines.
Help to ensure regulatory information and systems meet global compliance standards.
Help to develop and implement policies, SOPs, training materials, and guidelines for regulatory practices.
Champion innovation within submission processes to drive efficiency and maintain industry leadership.
Proven leadership in regulatory submission management to the US and regional markets.
Advanced knowledge of regional regulatory requirements for clinical trial applications, marketing authorisations and associated submissions, including eCTD and related software.
Expertise in regulatory information management systems (RIMS) and publishing solutions.
Strong project/program management skills and the ability to manage cross-functional teams.
Effective collaboration and communication skills with internal/external stakeholders and regulatory authorities.
Analytical and problem-solving skills to address complex regulatory and systems issues.
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 and 2 years of regulatory submissions or systems experience OR
Master’s degree and 8 to 10 years of regulatory submissions or systems experience OR
Bachelor’s degree and 10 to 14 years of regulatory submissions or systems experience OR
Diploma and 14 to 18 years of regulatory submissions or systems experience
Preferred Qualifications:
Extensive leadership in submission management of eCTD in US, Canada and submissions across Central and South America.
Advanced knowledge of global and regional regulatory requirements for submissions, including eCTD and related software.
Advanced expertise in regulatory publishing systems.
Strong project/program management skills and the ability to manage cross-functional teams.
Effective collaboration and communication skills with internal/external collaborators and regulatory authorities.
Analytical and problem-solving skills to address complex regulatory and systems issues.
Experience with global regulatory submission delivery
Experience with large-scale enterprise systems in the Biotech/Pharmaceutical industry.
Experience in regulatory operations, submission management.
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.