Regulatory Policy Lead
3 days ago
At AbbVie, our 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.
Job Description- Location flexibility is offered across Europe.
- This role reports directly into the Head of Europe, Regulatory Policy & Intelligence.
The Director, Europe Regulatory Policy & Intelligence (RPI), will be a 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.
This role leads specified regulatory policy topics in a collaborative cross-functional environment and works closely with counterparts from the US/C and Intercontinental areas.
The RPI Director addresses policy and intelligence gathering, analyzes changes in the regulatory environment, and develops policy positions and advocacy strategies to advance policy goals through internal and external collaboration.
This individual works closely with RA and cross-functional colleagues to coordinate policies ensuring alignment with AbbVie portfolio priorities.
The RPI Director establishes, develops, and maintains relations with HAs, peer company contacts, and industry trade associations regarding scientific and regulatory policies.
This role involves leadership of the development of cross-functional, multidisciplinary team responses to HA consultations.
Through provision of intelligence insights, the Director assists AbbVie to comply with scientific, ethical, statutory, quality, and business requirements.
Key Responsibilities- Manages global and/or regional topics in the regulatory policy and intelligence function, defining scientific and regulatory policy initiatives.
- Serves as policy subject expert based on in-depth knowledge of key regulatory and scientific issues, analyzing proposed policies and distributing to SMEs.
- 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.
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