Senior Associate, Regulatory Affairs Submission Management - Hybrid

📋 Description

• Manages medium to high impact (with respect to internal visibility, risk, complexity and
• Acts as RA Submissions interface with project teams providing guidance and communication of
• Plans and conducts submission team meetings. Expedites, manages, and coordinates multiple
• Coordinates submission publishing with offsite publishers/provides notification to ensure all
• May be a technical Subject Matter Expert troubleshooting issues and providing technical systems
• Facilitates the creation or procurement of submission content deliverables such as cover letters

🎯 Requirements

• Required Education: Bachelor’s degree. Note: Years of experience may also compensate for lower
• Preferred Education: PMP and RAC certificates a plus
• Required Experience: 4 years’ pharmaceutical or industry related experience with publishing related
• Preferred Experience: Experience in Regulatory Affairs preferred but may consider QA
• Proven leadership skills and presence
• NOTE: Higher education may compensate for years of experience.

🎁 Benefits

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
• This job is eligible to participate in our long-term incentive programs.