Regulatory Affairs Senior Associate
Amgen
13 hours ago
Remote friendly (United States)
United States
Corporate Functions
Regulatory Affairs Senior Associate
Responsibilities:
- Assist US Regulatory Lead (USRL) with US regulatory activities, including development and submission of INDs, BLAs, and NDAs; prepare for advisory committee meetings.
- Provide and maintain IND/BLA/NDA documentation support (e.g., annual reports, amendments) with USRL.
- Create and maintain product regulatory history documents; archive regulatory documents and agency communications in the regulatory document management system.
- Review the US component of the Global Regulatory Strategic Plan (GRSP) and provide input; perform regulatory research for GRSP content as delegated.
- Support regulatory compliance and ensure submissions to the US FDA are compliant.
- Prepare supportive documentation for global or US 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 meeting management (agendas, minutes).
- Assist USRL in responding to FDA questions.
- Coordinate quality checks (e.g., briefing packages) of regulatory documentation.
- Provide primary authorship for routine 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, standards development, metrics, and template development/maintenance.
- Respond to requests from and communicate issues to GRT; support development and execution of GRT goals.
Basic Qualifications:
- Master’s degree
- Or Bachelor’s degree + 2 years regulatory/pharmaceutical experience
- Or Associate’s degree + 6 years regulatory/pharmaceutical experience
- Or High school diploma/GED + 8 years regulatory/pharmaceutical experience
Application Instructions:
- Apply now. No application deadline; applications are accepted until a sufficient number is received or a candidate is selected.
Responsibilities:
- Assist US Regulatory Lead (USRL) with US regulatory activities, including development and submission of INDs, BLAs, and NDAs; prepare for advisory committee meetings.
- Provide and maintain IND/BLA/NDA documentation support (e.g., annual reports, amendments) with USRL.
- Create and maintain product regulatory history documents; archive regulatory documents and agency communications in the regulatory document management system.
- Review the US component of the Global Regulatory Strategic Plan (GRSP) and provide input; perform regulatory research for GRSP content as delegated.
- Support regulatory compliance and ensure submissions to the US FDA are compliant.
- Prepare supportive documentation for global or US 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 meeting management (agendas, minutes).
- Assist USRL in responding to FDA questions.
- Coordinate quality checks (e.g., briefing packages) of regulatory documentation.
- Provide primary authorship for routine 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, standards development, metrics, and template development/maintenance.
- Respond to requests from and communicate issues to GRT; support development and execution of GRT goals.
Basic Qualifications:
- Master’s degree
- Or Bachelor’s degree + 2 years regulatory/pharmaceutical experience
- Or Associate’s degree + 6 years regulatory/pharmaceutical experience
- Or High school diploma/GED + 8 years regulatory/pharmaceutical experience
Application Instructions:
- Apply now. No application deadline; applications are accepted until a sufficient number is received or a candidate is selected.