Let’s do this. Let’s change the world. In this vital role you will be accountable for hiring, training and retaining talented regulatory CMC regulatory staff, in alignment with the operational objectives of the wider RA CMC department. The RA Associate Director (CMC) coordinates communication and collaboration with local and global leadership, to ensure the successful operation of the team, and achievement of goals and deliverables within their areas of responsibility. They are accountable for continuous improvement, through the development and refinement of processes, and partnership with colleagues in other functions to develop systems and automation tools that improve the speed and efficiency of operations over time. They exemplify the Amgen values and leadership attributes, represent Amgen with local stakeholders and ensure a culture of compliance within the team.
Roles & Responsibilities:
Ensures appropriate staffing to achieve department objectives through effective hiring, training, development and retention of staff
Ensures seamless interaction of the team with local and global peers and colleagues
Drives the culture of the team in alignment with the Amgen values and leadership attributes
Works with external stakeholders including local academic and industry partners to raise the profile of Amgen and careers in RA CMC
Works cross functionally to develop digital tools and automations to drive efficiency and speed in the delivery of submissions
Provides coaching, mentoring, and supports development of CMC Regulatory Affairs staff
Ensures compliance with local and global regulations and codes of conduct
Ensure the completeness and accuracy of internal regulatory data systems
Monitors business performance and recommends changes to address emerging issues and opportunities
Ensures timely completion of deliverables
Follow established department regulatory processes to ensure cross-product alignment
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 and 3 years of directly related experience OR
Master’s degree and 10 to 14 years of directly related experience OR
Bachelor’s degree and 14 to 16 years of directly related experience OR
Diploma and 18 to 20 years of directly related experience
Preferred Qualifications:
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience
Global regulatory CMC filing experience across different stages of development, regions and modalities
Experience leading matrixed organizations
Knowledge and Skills:
Organizational leadership, staff development and training
Operational excellence, process improvement and automation
Regulatory CMC-specific regulatory knowledge & experience
Application of AI digital tools and automation
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.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com