Associate Director, RA Global Regulatory Strategy

Summary

Join AbbVie as an Associate Director, RA Global Regulatory Strategy, US & Canada, and be responsible for developing and implementing regulatory strategies for oncology products in the US and Canada. You will manage interactions with the FDA, advise internal teams on regulatory issues, and ensure compliance with regulations. This role requires strong communication, negotiation, and problem-solving skills, along with experience in pharmaceutical regulatory affairs. The preferred location is Lake County, Illinois, with a hybrid schedule, but remote work within the US is possible. AbbVie offers a comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k). This position also offers participation in short-term and long-term incentive programs.

Requirements

• Bachelor’s Degree (pharmacy, biology, pharmacology) or related life sciences
• 8 years Regulatory, R&D or Industry-related experience
• Demonstrates effective communication skills in written and oral channels
• Extensive experience interfacing with government Agencies and Health Authority personnel
• Able to deliver challenging messages effectively
• Experience working in a complex and matrix environment
• Demonstrated success in negotiation skills, strategic thinking, and credibility
• Strong communication skills, both oral and written

Responsibilities

• Develop and execute regulatory strategies for assigned products
• Manage interface with Health Authority (FDA) for key projects/issues
• Serve as primary liaison with FDA for meetings and teleconferences
• Advise internal customers on Regulatory/FDA issues
• Demonstrate excellent negotiation and problem-solving skills
• Operate independently, consulting management when necessary
• Make decisions and plan operations within area of responsibility
• Assist in the development, training, and mentoring of staff members
• Coordinate, prepare, and/or supervise regulatory submissions
• Ensure application of established policies and best practice regulatory standards
• Demonstrate solid understanding of current US and Canada regulations
• Apply regulatory/technical knowledge across therapeutic areas
• Present pertinent regulatory information to cross-functional areas
• Operate in compliance with regulations, company policies, and guidance

Preferred Qualifications

• Relevant advanced degree
• Certification
• 5 years in pharmaceutical regulatory affairs
• Proven skill at implementing successful US and Canada regulatory strategies; global regulatory experience is a plus

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs