Associate Director, Regulatory Affairs, Europe Regulatory Policy & Intelligence

Job description

Reporting the Head of Europe, Regulatory Policy & Intelligence. Position Overview: 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. Ability to assimilate policy trends in the European Union, and engage with impact, in the external environment is a key capability for this role. Policy experience in life science environment is required. 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. The individual will work closely with RA and cross functional colleagues to coordinate policies to ensure alignment with AbbVie portfolio priorities. The Europe RPI Associate Director develops, and maintains relations with HAs, peer company, and industry trade associations regarding scientific and regulatory policies, guided by company priorities. The role involves leadership of the development of cross-functional, multidisciplinary team responses to HA consultations, with a focus on aligning with company positions and scientific rigor. Through the provision of intelligence insights, the Associate Director assists company to comply with scientific, ethical, statutory, quality, and business requirements. Highlighted Responsibilities: 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 issue and scientific basis. Analyses 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. 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 with demonstrated ability to assimilate policy trends, propose policy solutions with capability to influence internally and externally. Exceptional communication skills are needed 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 advantag AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.