Associate Director, Regulatory Affairs, Europe Regulatory Policy

h3Company Description /h3 pbAbout AbbVie /b /p pAbbVie'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. /p h3Job Description /h3 pReporting the Head of Europe, Regulatory Policy Intelligence. /p pbPosition Overview: /b /p pThe 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 RD. 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. /p pThe 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. /p pThe 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. /p pbHighlighted

Responsibilities:
/b /p ul liIndependently 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. /li liServes 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. /li liPrepares 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. /li liEffectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates and communicates consequences of path chosen. /li liServes as liaison to trade associations for management on scientific and regulatory issues. /li liSupports supervisor and Senior Management in discussions of complex policy topics at trade associations. /li liContributes to regulatory product development strategy by responding to information requests and providing an analysis of the regulatory environment. /li liConducts 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. /li /ul h3Qualifications /h3 ul liDegrees in Pharmacy, Chemistry, Biology, Relevant Master’s degree or PhD in a scientific, health, legal, or business discipline preferred. /li liProven experience with the pharmaceutical industry or with a health authority /li liRegulatory policy and intelligence experience, including experience with trade associations, either from work in the pharmaceutical industry or at a health authority. /li liRobust knowledge of healthcare regulations in support of drug development, including experience in interpretation. /li liExperience working in a complex and matrix environment with demonstrated ability to assimilate policy trends, propose policy solutions with capability to influence internally and externally. /li liExceptional communication skills are needed to translate complex data into high-value insights. /li liWell-established regulatory network across European countries /li liExperience with both medicines and medical devices would be an advantag /li /ul h3Additional Information /h3 pAbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. /p pEqual Opportunity Employer/Veterans/Disabled. /p pUS Puerto Rico only
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