Director, Europe Regulatory Affairs Policy & Intelligence (Flexible Location)

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

• Location can be flexible across Europe
• Reporting into the Head of Europe, Regulatory Policy & Intelligence

Position Overview:

The 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 the European region. The Europe RPI Director will lead specified regulatory policy topics in a highly collaborative cross-functional environment and will work closely with counterparts from the US/C and Intercontinental areas. The role will address policy and intelligence gathering, analysis of changes in the regulatory environment and the impact of these changes to AbbVie, 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 Director establishes, develops, and maintains relations with HAs, peer company contacts, and industry trade associations regarding scientific and regulatory policies. The role involves leadership of the development of cross-functional, multidisciplinary team responses to HA consultations. Through the provision of intelligence insights, the Director assists AbbVie to comply with scientific, ethical, statutory, quality, and business requirements.

Key Responsibilities:

• Independently manages and leads global and/or regional topics in the regulatory policy and intelligence function. Defines scientific and regulatory policy initiatives.
• Serves as policy subject expert based on in depth knowledge of key regulatory and scientific issues. Analyzes proposed policies and distributes to SMEs. Leads formation of corporate position to share with trade associations.
• Mentors junior staff in approaches to complex policy issues.
• Prepares and presents complex written and oral reports to Senior Management and external audiences on scientific and regulatory topics.
• Proposes sound regulatory policies influencing the regulatory environment in one or more geographic regions.
• Effectively uses negotiation skills to resolve policy issues when unable to agree internally. Anticipates 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. May offer alternative views based on regulatory knowledge and prior experience.

Qualifications

• Bachelor’s degree related to health, environment or politics. Degrees in Pharmacy, Chemistry, Biology, Pharmacology or Law are most relevant.
• Relevant Master’s degree in a scientific, health, legal, or business discipline.
• Policy experience is required either within the Pharmaceutical industry or a health authority.
• Robust knowledge of healthcare regulations in support of drug development.
• Proven leadership skills with strong managerial and research skills
• Experience working in a complex and matrix environment.
• Strong communication skills, both oral and written.
• Well-established regulatory network

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only – to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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