Senior Associate Regulatory Affairs
Amgen
September 02, 2026
Remote friendly (United States)
United States
Corporate Functions
Senior Associate - Regulatory Affairs
What You Will Do
- Assist US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
Responsibilities (Key)
- Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
- Prepare, deliver, and electronically archive documentation for inclusion in US regulatory submissions.
- Support local regulatory activities (e.g., IND submissions and agency meetings).
- Provide and maintain CTA/MA documentation support (initial filings, amendments, periodic reports) with the US Regulatory Lead.
- Create and maintain product regulatory information and history documents through Amgen systems.
- Archive regulatory documents and agency communications.
- Collaborate with CROs/partners to support site initiation.
- Complete regulatory forms to support agency communications.
- Participate in GRT to support execution of regulatory strategy.
- Coordinate QC of regulatory documentation (e.g., briefing materials).
- Provide primary authorship to routine regulatory correspondence (e.g., annual reports, investigator packages).
- Assist in template development and maintenance.
- Respond to requests and communicate relevant issues to GRT.
- Actively support regulatory compliance.
Qualifications
Basic Qualifications:
- Master’s degree; or
- Bachelor’s degree and 2 years of Regulatory Affairs experience; or
- Associate’s degree and 6 years of Regulatory Affairs experience; or
- High school diploma/GED and 8 years of Regulatory Affairs experience.
Preferred Qualifications:
- Strong oral/written communication.
- Ability to understand and communicate scientific/clinical information.
- Collaboration, planning/organizing, prioritization, and ability to deal with ambiguity.
- Cultural awareness and sensitivity; ability to influence others.
What You Can Expect Of Us (Benefits)
- Total Rewards Plan (eligibility-based): comprehensive employee benefits, discretionary annual bonus (or sales incentive for field), stock-based long-term incentives, award-winning time-off, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications accepted until a sufficient number is received or a candidate is selected.
What You Will Do
- Assist US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
Responsibilities (Key)
- Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements.
- Prepare, deliver, and electronically archive documentation for inclusion in US regulatory submissions.
- Support local regulatory activities (e.g., IND submissions and agency meetings).
- Provide and maintain CTA/MA documentation support (initial filings, amendments, periodic reports) with the US Regulatory Lead.
- Create and maintain product regulatory information and history documents through Amgen systems.
- Archive regulatory documents and agency communications.
- Collaborate with CROs/partners to support site initiation.
- Complete regulatory forms to support agency communications.
- Participate in GRT to support execution of regulatory strategy.
- Coordinate QC of regulatory documentation (e.g., briefing materials).
- Provide primary authorship to routine regulatory correspondence (e.g., annual reports, investigator packages).
- Assist in template development and maintenance.
- Respond to requests and communicate relevant issues to GRT.
- Actively support regulatory compliance.
Qualifications
Basic Qualifications:
- Master’s degree; or
- Bachelor’s degree and 2 years of Regulatory Affairs experience; or
- Associate’s degree and 6 years of Regulatory Affairs experience; or
- High school diploma/GED and 8 years of Regulatory Affairs experience.
Preferred Qualifications:
- Strong oral/written communication.
- Ability to understand and communicate scientific/clinical information.
- Collaboration, planning/organizing, prioritization, and ability to deal with ambiguity.
- Cultural awareness and sensitivity; ability to influence others.
What You Can Expect Of Us (Benefits)
- Total Rewards Plan (eligibility-based): comprehensive employee benefits, discretionary annual bonus (or sales incentive for field), stock-based long-term incentives, award-winning time-off, and flexible work models where possible.
Application Instructions
- Apply now via careers.amgen.com; no application deadline—applications accepted until a sufficient number is received or a candidate is selected.