Associate Director, Regulatory Affairs, Europe Regulatory Policy & Intelligence
关于 AbbVie,阿伯维的使命是发现和提供解决当今严重健康问题并应对明天医疗挑战的创新药物和解决方案。我们努力在包括免疫学，肿肿瘤学和神经科学等几个关键治疗领域中对人们的生活产生显著影响 - 以及我们的 Allergan Aesthetics 产品和服务组合中的产品和 සේවා.有关 AbbVee 的更多信息请访问 www.abbvie.com. @abbvie 在 LinkedIn,Facebook,Instagram,X 和 YouTube 上。报告欧洲负责人，监管政策 & 情报总结：欧洲监管政策和情报副主任将成为监管政策与程序，法律法规的强有力的专家，对监管政策在欧洲如何形成和发展以及研发业务背景全面了解。能够吸收欧盟的政策趋势并参与外部环境的影响是这一角色的主要能力。需要生命科学环境中的政治经验。该角色将涉及政策和情报融入，监管环境变化的分析，制定政策立场和倡导策略以通过内部和外部合作推进政策目标。个人将与 RA 以及跨职业同事密切合作，协调政策，确保与 AbbVie 投资组合优先事项相一致。欧洲 RPI 副主任发展并维护与 HAs,同行公司和行业贸易协会有关科学和监管政策的关系，受公司优先事项指导。负责领导跨职业，多学科的团队对 HA 咨询的反应开发，重点与公司立场和科学严格结合。通过提供情报见解，副总监协助公司遵守科学，伦理，法定，质量和商业要求。突出责任：·独立管理并领导监管政策和情报功能中的区域主题。定义了分配领域内的科学和监管政策举措。需要高水平的积极性和商业敏度。·作为政策专家，基于对关键监管问题和科学基础的深入知识。分析提出的政策，明确强调沟通
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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 www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
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.
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