Senior Regulatory Affairs Associate

Role Overview

• 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.