Regulatory Policy and Intelligence Analyst

Washington, DC 20005

Posted: 01/20/2019 Employment Type: Contract Industry: Regulatory Affairs & Compliance Job Number: 5443

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Description:

The person in this role will be expected to provide support for the U.S. Lead for Technical Regulatory Policy in various intelligence activities including but not limited to establishing a sustained regulatory intelligence method enabling to collect, analyze and disseminate regulatory intelligence information. Regulatory Policy and Regulatory Intelligence Analyst will build upon the initial efforts to operationalize the regulatory intelligence initiatives by reviewing competitor’ s interactions with regulatory bodies (e.g., The European Medicines Agency and the US Food and Drug Administration) and monitoring and assessing relevant industry benchmarking efforts.

 

Deliverables:
  • Support efforts to respond to Health Authorities’ Guidance documents, assess the impact to the organization and maintain the commenting database
  • Conference and Public meeting coverage – summary report generation and dissemination
  • Regulatory information gathering and dissemination – to include daily scanning of Federal Register, FDA.gov, RAPS, and other newsfeeds
  • Interpret FDA, EMA, ICH Guidance documents
  • Mine SBA/EPAR and Cortellis for personalized medicine and other products under development and those receiving regulatory approval and generate summary reports

 

Essential Skills:

  • Data mining, analysis & interpretation: An ability to understand complex unstructured data, and relate it to both internal and external business drivers
  • A highly motivated individual with excellent organizational skills
  • A rapid learner with an ability to absorb, analyze and dissect large amounts of information
  • Support the role of line manager to facilitate policy goals are reached
  • Manage multiple project independently
  • Volunteer for new tasks and projects
  • Results-oriented with an eagerness to learn, ask questions, and take initiative
  • Respond well to direct feedback and self-correct as needed

 

Technical Skills:

  • Proficient in Microsoft Office and Google platforms
  • A knowledge of life sciences highly desired 
  • A basic understanding of the drug development process, late-stage process development, and small molecule/biologic manufacturing desirable
  • An interest in regulatory policy, technological innovation and business

 

Communication:  

  • Effectively communicate with line manager and stakeholders to inform of project status and strategy in accordance with defined role 
  • Communicates project challenges to line manager in an appropriate and timely manner. 
  • Displays high degree of capability in assigned written and oral presentation

 

Education:

  • Bachelor's degree or higher in a relevant scientific discipline
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