BASIC QUALIFICATIONS:

Master’s degree OR
Bachelor’s degree & 2 years of Regulatory experience OR
Associates degree & 6 years of Regulatory experience OR
High school diploma / GED & 8 years of Regulatory experience

PREFERRED QUALIFICATIONS:

• Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
• Regulated industry, science or clinical practice experience
• Timeline management
• Strong communication skills- oral and written
• Organizational skills
• Ad hoc meeting support

Let’s do this. Let’s change the world. In this key role you will, under the direction of a Regional Regulatory Lead, assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Key responsibilities include:

• Assist US Regulatory Lead to support US regulatory activities (e.g. IND development and submission, meeting preparations)
• Provide and maintain IND/BLA documentation support (e.g. annual reports, amendments) in collaboration with US Regulatory Lead (and Regional Reg Leads, as appropriate)
• Create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications
• Review US component of the Global Regulatory Strategy Plan and provide input to operational deliverables
• Ensure compliance with submissions to regulatory agencies
• Coordinate collection of functional documents in support of regulatory applications
• As appropriate facilitate and participate in GRT to support the implementation of regulatory strategy
• Coordinate QC of regulatory documentation (e.g. briefing packages)
• Provide primary authorship to routine regulatory correspondence, if needed (cover letters, etc.)
• Prepare regulatory packages and cross-reference letters to support investigator initiated studies
• Assist USRL and GRL, as needed
• Complete regulatory forms to support agency communications
• Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions, as needed
• Support process improvement initiatives, standards development, and metrics
• Assist in template development and maintenance, as needed
• Respond to specific requests from and communicate relevant issues to GRT
• Assist in development of Regulatory Position with teams
• Actively support regulatory compliance