Regulatory Affairs Senior Associate
Amgen
June 27, 2026
Remote friendly (United States)
United States
Corporate Functions
Regulatory Affairs Senior Associate
Responsibilities:
- Assist US Regulatory Lead (USRL) with US regulatory activities, including IND, BLA, and NDA development/submission and advisory committee meeting preparations.
- Provide and maintain IND/BLA/NDA documentation support (e.g., annual reports, amendments).
- Create and maintain product regulatory history documents; archive regulatory documents and agency communications.
- Review US component of the Global Regulatory Strategic Plan (GRSP); conduct regulatory research to support GRSP content.
- Support regulatory compliance and ensure submissions to the US FDA.
- Prepare supportive documentation for regulatory deliverables (e.g., regulatory landscapes, label/strategy research).
- Coordinate collection of functional documents for regulatory applications.
- Participate on Global Regulatory Teams (GRT) and support GRT meeting management (agendas, minutes).
- Assist USRL with responding to FDA questions.
- Coordinate Quality Check (QC) of regulatory documentation (e.g., briefing packages).
- Provide primary authorship for routine regulatory correspondence (e.g., annual reports).
- Prepare regulatory packages and cross-reference letters for investigator-initiated studies.
- Complete regulatory forms for agency communications (e.g., FDA Form 1571).
- Support process improvement initiatives, standards development, and metrics.
- Assist with template development and maintenance; respond to GRT requests and communicate issues.
Qualifications:
- Master’s degree OR Bachelor’s degree with 2 years of regulatory/pharmaceutical experience OR Associate’s degree with 6 years OR High school diploma/GED with 8 years.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or selected.
Benefits (as stated):
- Health and welfare plans; financial plans for retirement/savings; work/life balance; career development; retirement and savings plan with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.
Responsibilities:
- Assist US Regulatory Lead (USRL) with US regulatory activities, including IND, BLA, and NDA development/submission and advisory committee meeting preparations.
- Provide and maintain IND/BLA/NDA documentation support (e.g., annual reports, amendments).
- Create and maintain product regulatory history documents; archive regulatory documents and agency communications.
- Review US component of the Global Regulatory Strategic Plan (GRSP); conduct regulatory research to support GRSP content.
- Support regulatory compliance and ensure submissions to the US FDA.
- Prepare supportive documentation for regulatory deliverables (e.g., regulatory landscapes, label/strategy research).
- Coordinate collection of functional documents for regulatory applications.
- Participate on Global Regulatory Teams (GRT) and support GRT meeting management (agendas, minutes).
- Assist USRL with responding to FDA questions.
- Coordinate Quality Check (QC) of regulatory documentation (e.g., briefing packages).
- Provide primary authorship for routine regulatory correspondence (e.g., annual reports).
- Prepare regulatory packages and cross-reference letters for investigator-initiated studies.
- Complete regulatory forms for agency communications (e.g., FDA Form 1571).
- Support process improvement initiatives, standards development, and metrics.
- Assist with template development and maintenance; respond to GRT requests and communicate issues.
Qualifications:
- Master’s degree OR Bachelor’s degree with 2 years of regulatory/pharmaceutical experience OR Associate’s degree with 6 years OR High school diploma/GED with 8 years.
Application Instructions:
- Apply at careers.amgen.com. No application deadline; applications continue until sufficient candidates are received or selected.
Benefits (as stated):
- Health and welfare plans; financial plans for retirement/savings; work/life balance; career development; retirement and savings plan with company contributions; group medical/dental/vision; life and disability insurance; flexible spending accounts; discretionary annual bonus; stock-based long-term incentives; time-off plans; flexible work models where possible.