Senior Regulatory Affairs Operations Specialist

Join our global diversified pharmaceutical company as a Senior Regulatory Affairs Operations Specialist. This role will be responsible for compiling and submitting regulatory submissions to Health Authorities and maintaining submission data in Regulatory Affairs systems.

Requirements

• Bachelor’s degree preferred
• Experienced technical skills for the preparation, publishing, and archiving of regulatory documents
• Knowledgeable about the FDA and Health Canada eCTD submissions lifecycle management
• Proficient in eCTD format and regulatory submission requirements
• Working knowledge of document management systems and regulatory publishing tools
• Ability to balance multiple tasks while meeting priorities and timelines
• Experienced in leading the management of submissions and timelines and collaborating with team members
• Demonstrate strong communication skills and the ability to work effectively within a team
• A minimum of 3 years of combined pharmaceutical and regulatory experience is preferred

Benefits

• Comprehensive Medical (includes Prescription Drug)
• Dental
• Vision
• Flexible Spending Accounts
• 401(k) with matching company contribution
• 3-weeks paid time off plus paid sick time
• Stock purchase plan
• Tuition reimbursement
• Parental leave
• Short- and long-term disability
• Life insurance
• Accidental death & dismemberment insurance
• 12 paid holidays (including floating holidays)
• Employee referral bonuses
• Employee discounts