Regulatory Affairs Specialist

Regulatory Affairs Specialist (Multiple Levels)

Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections. 
• Leads or compiles all materials required in submissions, license renewal and annual registrations. 
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking / control systems. Keeps abreast of regulatory procedures and changes. 
• May direct interaction with regulatory agencies on defined matters. 
• Recommends strategies for earliest possible approvals of clinical trials applications. 
• May act as a mentor to colleagues or may direct the work of other lower level professionals. 
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
• Recognized expert, managing large projects or processes 
• Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager 
• Coaches, reviews and delegates work to lower level specialists. 
• Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results

Requirements:

• Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience. 
• May have broad knowledge of project management. 
• Requires a University Degree and minimum:
  • Principal Role - 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
  • Senior - 4 years of relevant experience
  • Junior - 2 years of relevant experience

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