AbbVie

Associate Director, Regulatory Affairs, Europe Regulatory Policy & Intelligence

In short

This role leads regional regulatory policy and intelligence topics for a pharmaceutical company, acting as a subject-matter expert on regulatory and scientific issues across Europe. It involves preparing complex reports for senior management, liaising with trade associations, and resolving policy issues through negotiation. The position requires a scientific/health-related degree and proven experience in pharmaceutical regulatory affairs or with a health authority.

Description
•Independently manages and leads regional topics in the regulatory policy and intelligence function.
•Serves as policy subject expert based on in-depth knowledge of key regulatory issues and scientific matters.
•Prepares and presents complex written and oral reports to Senior Management and external audiences.
•Effectively uses negotiation skills to resolve policy issues when unable to agree internally.
•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.
Requirements
•Degree in Pharmacy, Chemistry, Biology, relevant Master's degree or PhD in a scientific, health-related field.
•Proven experience with the pharmaceutical industry or with a health authority.
•Regulatory policy and intelligence experience, including experience with trade associations.
•Robust knowledge of healthcare regulations in support of drug development.
•Experience working in a complex and matrix environment with demonstrated ability to assimilate information.
•Exceptional communication skills needed to translate complex data into high-value insights.

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