Associate Director, Regulatory Affairs Advertising and Promotion Job at Biogen i

Overview

• Salary up to $206,000.00
• Opportunity for career advancement and growth within a pioneering biotechnology company
• Comprehensive benefits package including medical, dental, vision, and life insurance
• Generous paid time off policy including a minimum of 15 days of vacation and additional holidays
• Supportive work environment that values inclusion and diversity
• Participation in employee resource groups and tuition reimbursement up to $10,000 per year

Responsibilities

• Provide regulatory strategic input and risk assessment for promotional and medical communications
• Serve as the primary contact with the Office of Prescription Drug Promotion (OPDP) for designated products
• Ensure compliance of promotional materials with FDA regulations and submission requirements
• Develop strong working relationships with cross-functional teams including Commercial, Medical, and Legal
• Assist in monitoring the evolving regulatory landscape and communicate updates to stakeholders

Qualifications

• BS degree required; advanced degree preferred
• Minimum of 5 years of experience in regulatory promotional review
• Detail-oriented with strong organizational skills
• Ability to analyze risk and communicate effectively across teams
• Exceptional verbal, written, and presentation skills

Preferred Qualifications

• Experience in a fast-paced and compliant environment
• Proven negotiation and interpersonal skills to influence and build collaboration
• Familiarity with complex disease information and product efficacy/safety data

#Biotechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #DiversityAndInclusion

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