Director Europe Regulatory Affairs Policy Intelligence Flexible Location
Director Europe Regulatory Affairs Policy Intelligence Flexible Location
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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 crossfunctional 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 crossfunctional 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 :
- Bachelors degree related to health environment or politics. Degrees in Pharmacy Chemistry Biology Pharmacology or Law are most relevant.
- Relevant Masters 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.
- Wellestablished 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 AbbVies 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.
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Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
