Associate Director, Regulatory Affairs, Europe Regulatory Policy and Intelligence (all genders) (fulltime, regular)

Welcome to AbbVie! As part of an international company with ca. 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as Associate Director, Regulatory Affairs, Europe Regulatory Policy and Intelligence (all genders)

The Associate Director, Europe Regulatory Policy & Intelligence (RPI), will be a strong subject matter expert in regulatory policy and procedure, laws and regulations with a comprehensive understanding of how regulatory policy is shaped and developed within Europe, and the business context for R&D. Also, in this role you will lead assigned regulatory policy topics in a collaborative cross-functional environment and will work closely with counterparts from US/C and JPAC. The role will address policy and intelligence assimilation, analysis of changes in the regulatory environment, development of policy positions and advocacy strategies to advance policy goals through internal and external collaboration to ensure alignment with AbbVie portfolio priorities.

Make your mark:

• Independently manages and leads regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives within assigned areas. A high level of proactivity and business acumen is required.
• Serves as policy subject expert based on in depth knowledge of key regulatory issues and scientific basis. Analyzes proposed policies with clear emphasis on communicating impact of trends. Leads formation of corporate position to share with trade associations, ensuring cross functional alignment.
• Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics. Exceptional communication skills are needed to translate complex data into high-value insights.
• Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates and communicates consequences of path chosen.
• Serves as liaison to trade associations for management on scientific and regulatory issues.
• Supports supervisor and Senior Management in discussions of complex policy topics at trade associations.
• Contributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment.
• Conducts external outreach with regulators, peers, and trades. Creates and responds to opportunities to enhance AbbVie’s relationship by participating in policy-related meetings. Utilizes local network of pharma companies to obtain policy-related information.