Analyst, Regulatory Affairs- Regulatory Policy and Intelligence

The Analyst Regulatory Policy and Intelligence (RPI) support the US RPI function by conducting research on regulatory intelligence questions and topics within assigned areas and regions.  Responsibilities include analyzing and utilizing relevant regulatory approval databases as well as preparing and delivering regulatory intelligence summaries both orally and in writing.

The Analyst should be comfortable working in a dynamic environment and proactively contributing new ideas and process improvements that enhance assigned projects.

The Analyst also serves as the office manager for the Rockville MD location and should be comfortable assisting with general office duties. This includes oversight of rental and service agreements office maintenance office equipment coordination with real estate affiliates suite and building safety and security parking support IT upgrades and support coordinating logistics for office visitors and management of on-site deliveries including after-hours as needed.

Analyst 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.

• Office Manager Responsibilities:
• 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.

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications :

• Bachelors 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 Experience:

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

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic locationand we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our short-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of anybonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys soleand absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law. 

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time