Strategist

Archetype 8 Strategist

Most strategists should excel at:

  • Establishing long-range objectives and specifying the strategies and actions to achieve them.
  • Analyzing information and evaluating results to choose the best solution and solve problems.
  • Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Scheduling events, programs, and activities, as well as the work of others.

Analyzer

Archetype 3 Analyzer

Analyzers will often perform the following tasks:

  • Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.
  • Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.
  • Assessing the value, importance, or quality of things or people.
  • Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Other work activities related to Regulatory affairs specialists

  • Communicating with regulatory agencies regarding pre submission strategies, potential regulatory pathways, compliance testing requirements, or clarification and following up of submissions under reviewing.
  • Escorting government inspectors during inspections and providing post inspection following up information as requested.
  • Coordinating, preparing, or reviewing regulatory submissions for domestic or international projects.
  • Interpreting regulatory rules or rule changes and ensuring that they are communicating through corporate policies and procedures.
  • Providing technical reviewing of data or reports to be incorporated into regulatory submissions for assuring scientific rigor, accuracy, and clarity of presentation.
  • Reviewing product promotional materials, labeling, batch records, specification sheets, or testing methods for compliance with applicable regulations and policies.
  • Advising project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical compliance issues with the studies.