Senior Regulatory Affairs Associate
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Job Description
Regulatory Affairs Senior Associate at Amgen assisting in regulatory document creation and submission. Supporting US regulatory activities and compliance under USRL supervision.
Responsibilities:
- Assist US Regulatory Lead (USRL) to support US regulatory activities (e.g. development and submission of Investigational New Drug [IND] applications, Biologic License Applications [BLAs] and New Drug Applications [NDAs]; advisory committee meeting preparations)
- Provide and maintain IND/BLA/NDA documentation support (e.g. annual reports, amendments) in collaboration with USRL
- Create and maintain product regulatory history documents in the regulatory document management system and appropriately archive all regulatory documents and agency communications
- Review US component of the Global Regulatory Strategic Plan (GRSP) and provide input to operational deliverables; perform regulatory research to support the development of content for the GRSP plan as delegated by the Global or US Regulatory Lead
- Actively support regulatory compliance and ensure compliance of submissions to the US FDA
- Assist the Global or US Regulatory Lead by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label
- Coordinate collection of functional documents in support of regulatory applications
- Participate on Global Regulatory Teams (GRT) and assist Global Regulatory Leads with GRT meeting management (eg, agendas and meeting minutes)
- Assist the USRL in managing the process for responding to FDA questions
- Coordinate Quality Check (QC) of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Complete regulatory forms to support agency communications (e.g. FDA form 1571)
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Support the development and execution of GRT goals
Requirements:
- Master’s degree
- Or Bachelor’s degree and 2 years of regulatory or pharmaceutical experience
- Or Associate’s degree and 6 years of regulatory or pharmaceutical experience
- Or High school diploma / GED and 8 years of regulatory or pharmaceutical 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, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible.
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