Analyst, RA Regulatory Policy And Intelligence

Abbvie, Inc Rockville , MD 20850

Posted 2 months ago

The Analyst, Regulatory Policy and Intelligence (RPI) supports the RPI function by researching questions and areas of regulatory intelligence for assigned topics and regional area(s), including the interrogation and support of applicable databases of regulatory approval information. The incumbent prepares and articulates regulatory intelligence summaries orally and in writing. The incumbent should also be comfortable working in an environment where they can proactively bring forward new ideas and processes impacting their assigned projects.

Major Responsibilities:

  • Review and evaluate regulatory intelligence for assigned region(s) and topics. Partners with RPI policy topic and/or regional leads for additional context and assessment.

  • Support business compliance through raising awareness of new requirements (regulations, guidelines, health authority notices and announcements), by communicating to AbbVie subject matter experts (SMEs), quality compliance experts (QCEs) and other relevant colleagues via GRIP notifications and other channels

  • Partnership role with affiliates for identification of significant national regulatory intelligence information, and communication to stakeholders

  • Support analysis of regulatory trends in the environment in key areas of interest to AbbVie

  • Conduct sophisticated searches of regulatory intelligence sources and present findings in a summary that can be communicated within AbbVie

  • Conducts research to respond to regulator policy and procedure questions received from colleagues in the business.

  • Prepare supporting material for regulatory policy topics

  • Support other regulatory intelligence activities as needed.

Required Education:

  • Bachelor's degree required preferably in a science related to health, the environment, or politics

Preferred Education:

  • Regulatory certifications a plus

Required 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

Preferred Experience :

  • Regulatory intelligence gathering and analysis

  • Good understanding of regulatory environment including regulatory pathways

Note: Higher education may compensate for years of experience and vice versa

Additional Information

  • Significant Work Activities and Conditions: Keyboard use (greater or equal to 50% of the workday), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

  • Travel: Yes, 5 % of the Time

  • Job Type: Experienced

  • Schedule: Full-time

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Analyst, RA Regulatory Policy And Intelligence

Abbvie, Inc