Associate Director Regulatory Affairs

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.

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