Senior Regulatory Affairs Specialist

Responsible for supporting all aspects of regulatory compliance, submission preparation, and product lifecycle management. Provides cross-functional support to ensure compliance with pharmacovigilance reporting requirements.

Requirements

• Bachelor's degree in a scientific area of interest
• 3-5 years Regulatory experience in a Pharmaceutical Environment
• Regulatory Affairs Certification (preferred)
• Ability to multitask and manage multiple projects with interdisciplinary teams
• Effective communication (verbal and written) with external and internal customers, vendors, and regulators
• Strong planning and organizational / project / workload management skills
• Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects
• Ability to work independently as well as in a team environment
• Ability to drive projects to completion with minimal guidance
• Solid interpersonal (verbal and written) communication skills at all levels
• Formal project management skills (plus)
• Experience with PC-based word processing software, databases, spreadsheets, and Adobe Acrobat, including database management and support
• Experience with metrics management and reporting
• Proven negotiation skills with internal and external stakeholders

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Tuition Reimbursement