Sr Manager/Assoc Director, Regulatory Operations

📋 Description

• Support Regulatory Affairs submissions including: Partner with Regulatory Leads and
• Support Regulatory Affairs Department operations, including: Maintain accurate regulatory
• Perform all duties in keeping with the Company’s core values, policies, and all applicable

🎯 Requirements

• Undergraduate degree required, advanced degree preferred; RAC certification a plus
• 6+ years of relevant experience in Regulatory Operations or a closely related field; experience in
• Sound knowledge of drug development strategies and regulations
• Experience supporting or preparing a marketing application (NDA/BLA/MAA) or a major amendment in a
• Hands-on experience with regulatory information management or electronic document management
• Strong project management skills, with the ability to manage strategic deadlines, changing

🎁 Benefits

• Paid Time Off, Holiday, and Sick Leave
• Medical, Dental and Vision Plans
• Short- and Long-Term Disability
• Basic and Voluntary Life/AD&D Coverage
• Flexible Spending Accounts (FSA, HSA, and Commute)
• Critical Illness and Accident Coverage