Associate Director, Regulatory Affairs, Europe Regulatory Policy – Intelligence

• Report to the Head of Europe, Regulatory Policy & Intelligence
• Manage and lead regional topics in the regulatory policy and intelligence function
• Define scientific and regulatory policy initiatives within assigned areas
• Serve as a policy subject expert based on in-depth knowledge of key regulatory issues and scientific basis
• Analyze proposed policies and communicate the impact of trends
• Lead formation of corporate positions for sharing with trade associations, ensuring cross-functional alignment
• Prepare and present complex written and oral reports to senior management and external audiences
• Use negotiation skills to resolve policy issues and communicate consequences of chosen paths
• Serve as liaison to trade associations on scientific and regulatory issues
• Support supervisor and senior management in discussions of complex policy topics at trade associations
• Contribute to regulatory product development strategy by responding to information requests and analyzing the regulatory environment
• Conduct external outreach with regulators, peers, and trade associations
• Participate in policy-related meetings to enhance AbbVie’s relationships
• Utilize local networks of pharmaceutical companies to obtain policy-related information
• Coordinate with regulatory affairs and cross-functional colleagues to align policies with AbbVie portfolio priorities
• Lead development of cross-functional, multidisciplinary team responses to health authority consultations
• Provide intelligence insights supporting compliance with scientific, ethical, statutory, quality, and business requirements

• Degrees in Pharmacy, Chemistry, Biology, relevant Master’s degree or PhD in a scientific, health, legal, or business discipline preferred
• Proven experience with the pharmaceutical industry or with a health authority
• Regulatory policy and intelligence experience, including experience with trade associations, either from work in the pharmaceutical industry or at a health authority
• Robust knowledge of healthcare regulations in support of drug development, including experience in interpretation
• Experience working in a complex and matrix environment
• Demonstrated ability to assimilate policy trends and propose policy solutions with capability to influence internally and externally
• Exceptional communication skills to translate complex data into high-value insights
• Well-established regulatory network across European countries
• Experience with both medicines and medical devices would be an advantage

• Employees can work remotely
• Equal opportunity employer
• Commitment to operating with integrity, driving innovation, transforming lives, and serving the community