Senior Associate – Regulatory Affairs
Amgen
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $88,347 - $110,633 per year
Job Level
About the role
- Assist the US Regulatory Leads and the Global Regulatory Team (GRT) in the Regulatory Affairs organization
- Coordinate and execute US regulatory submissions under the direction of the US Regulatory Lead in compliance with corporate standards and regulatory requirements
- Manage and execute the preparation, delivery, and electronic archiving of documentation for inclusion in US regulatory submissions
- Assist the Global Regulatory Lead to manage GRT interactions
- Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
- Create and maintain product regulatory information and history documents through Amgen systems
- Appropriately archive regulatory documents and agency communications
- Collaborate with CRO’s / 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 specific requests from and communicate relevant issues to GRT
- Actively support regulatory compliance
Requirements
- 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
Benefits
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
- group medical, dental and vision coverage
- life and disability insurance
- flexible spending accounts
- A discretionary annual bonus program
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models, including remote and hybrid work arrangements, where possible
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsdocumentation preparationelectronic archivingregulatory complianceQC of regulatory documentationregulatory correspondencetemplate developmentCTA documentationMA documentationregulatory strategy
Soft Skills
collaborationcommunicationcoordinationproblem-solvingattention to detailorganizational skillsinterpersonal skillsauthoring skillsresponsivenesssupportive attitude