Analyst, Regulatory Affairs- Regulatory Policy and Intelligence jobs in United States
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AbbVie · 12 hours ago

Analyst, Regulatory Affairs- Regulatory Policy and Intelligence

AbbVie is a company dedicated to discovering and delivering innovative medicines and solutions that address serious health issues. The Analyst, Regulatory Policy and Intelligence will support the US RPI function by conducting research on regulatory intelligence questions, analyzing regulatory trends, and preparing regulatory summaries. This role also includes office management responsibilities for the Rockville MD location.

BiotechnologyFinancial ServicesHealth CareMedicalPharmaceuticalVenture Capital
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Comp. & Benefits
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H1B Sponsor Likelynote

Responsibilities

Review and evaluate regulatory intelligence for assigned regions and topics, partnering with RPI policy topic and/or regional leads to provide context and assessment
Analyze regulatory trends in key areas of interest to AbbVie and provide insights to inform strategic decisions, leveraging Excel for data analysis and visualization
Conduct research to address regulatory policy and procedure questions received from business colleagues
Prepare supporting materials for regulatory policy topics, including presentations and summaries using PowerPoint for clear and impactful communication
Assist with regulatory policy and intelligence activities as needed, such as attending and documenting FDA virtual meetings
Co-manage and edit regulatory policy newsletters and other general communications, in partnership with RPI analysts in EU and Intercon regions
Support RPI staff by organizing routine meetings, developing agendas, preparing background materials, and drafting meeting summaries. Coordinate functional area goals and projects, including partnering with other functions to develop communications and presentations
Co-manage global departmental databases and SharePoint sites, ensuring accurate content management and leveraging information to provide recommendations to senior RPI staff. Responsibility shared with RPI analysts in EU and Intercon regions
Facilities: stock office and kitchen supplies; research, order, setup, clean up catering; equipment maintenance, repair, and inventory
Expenses: as necessary, prepare reports for RPI Directors and Senior Director
Key point of contact with landlord and AbbVie Real Estate for suite projects, including (but not limited to): security, real estate, accounting, painting, and carpet refreshes
Key RPI liaison contact to AbbVie product teams and individuals that use the office when visiting the area. Provide logistical support to AbbVie product teams and visiting colleagues using the Rockville office for FDA-related meetings or local engagements. This includes organizing transportation to FDA, arranging catering, and offering general assistance

Qualification

Regulatory intelligence analysisData analysis with ExcelRegulatory certificationsPowerPoint proficiencyPrimary research skillsInternet searchingWord proficiencyOffice managementCommunicationOrganizational skills

Required

Bachelor's degree required, Regulatory certifications a plus
6+ years of industry experience
Experience with Internet searching, Word, PowerPoint, and Excel. Demonstrated competency in conducting primary research and distilling large amounts of information into concise executive summaries
Excellent communicator in written and verbal forms & excellent organizational skills
Note: Higher education may compensate for years of experience and vice versa

Preferred

Regulatory intelligence gathering and analysis
Good understanding of regulatory environment including regulatory pathways

Benefits

Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)

Company

AbbVie is a biopharmaceutical company focused on immunology, oncology, neuroscience, virology, and aesthetics. It is a sub-organization of AbbVie.

H1B Sponsorship

AbbVie has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (273)
2024 (190)
2023 (225)
2022 (284)
2021 (186)
2020 (186)

Funding

Current Stage
Public Company
Total Funding
$15B
2024-02-27Post Ipo Debt· $15B
2023-03-08Post Ipo Equity· $0.25M
2012-12-20IPO

Leadership Team

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Robert Michael
Chairman of the Board and Chief Executive Officer
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Micah Bregman
Vice President, Global Strategy and Pipeline, Allergan Aesthetics
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Company data provided by crunchbase