Associate Director Regulatory Affairs

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
• Masters degree and 10 to 14 years of directly related experience OR
• Bachelors 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.