Senior Regulatory Affairs Specialist - Drive Global Submissions

Amgen SA; Northern (KY); Hybrid; USD 95,000 - 130,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus

Job summary

Amgen, a leader in biotechnology, seeks a Senior Associate in Regulatory Affairs to support regional regulatory activities and ensure compliance with evolving regulatory standards. This role involves preparing submissions, maintaining regulatory documentation, and guiding cross-functional teams to meet agency expectations.

You will coordinate regulatory materials, contribute to GRSP plans, and assist Global or Regional leads in regulatory strategy, timelines, and messaging.

Qualifications

• Master’s or bachelor’s degree with regulatory affairs experience.
• Experience preparing regulatory submissions and guidance to teams.
• Familiarity with regulatory legislation changes and compliance.

Responsibilities

• Support regional regulatory activities under the Regional Regulatory Lead.
• Maintain IND/MA documentation and regulatory history through RIM.
• Archive regulatory documents and agency communications appropriately.
• Review GRSP regional components and contribute to operational deliverables.
• Ensure submissions comply with regulatory agencies and respond to questions.
• Coordinate collection of regulatory documents and assist in GRT meetings.
• Prepare supportive documentation for regulatory deliverables and strategies.
• Assist in template development and process improvements.

Skills

Regulatory affairs experience

Regulatory submissions

Education

Master’s degree

Bachelor’s degree + 2 years Regulatory Affairs

Associate’s degree + 6 years Regulatory Affairs

High school diploma / GED + 8 years Regulatory Affairs

Job description

Amgen, a leader in biotechnology, seeks a Senior Associate in Regulatory Affairs to support regional regulatory activities and ensure compliance with evolving regulatory standards. This role involves preparing submissions, maintaining regulatory documentation, and guiding cross-functional teams to meet agency expectations.

You will coordinate regulatory materials, contribute to GRSP plans, and assist Global or Regional leads in regulatory strategy, timelines, and messaging.