Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist executes on the pharmaceutical regulatory strategies for assigned brand products, supporting regulatory aspects of product development teams and liaising with country-specific regulatory personnel.

Requirements

• 4+ years relevant pharmaceutical industry and regulatory experience (or 2+ years Pharmaceutical Brand Experience with a Masters in Regulatory Affairs)
• Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle
• Knowledge of domestic and international regulations laws, regulations, and guidance
• Ability to partner within regulatory and with cross-functional teams in a pharmaceutical organization
• Excellent communication skills; both oral and written
• Strong interpersonal skills with the ability to influence others in a positive and effective manner

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