Staff Regulatory Specialist
1 month ago
8+ years of work experience with educational qualification BS in Engineering, Science, or related degree; or MS in Regulatory Science
Great to have certifications around MS or RAC(s) preferred.
Strong project management, writing, coordination, and execution of regulatory items
Emphasis on technical and scientific regulatory activities
Demonstrate knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance and distribution.
Under general supervision, plans, conducts and supervises assignments.
Reviews progress and evaluates results.
Recommends changes in procedures.
Operates with appreciable latitude for unreviewed action or decision.
Reviews progress with management
May direct work of Specialist or Sr. Specialist
Seeks out diverse ideas, opinion, and insights and applies them in the workplace
Connects and relates well with people who think and act differently than oneself
Embraces scrutiny and accepts feedback as opportunity to learn and improve
Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources.
Navigates the dynamics, alliances, and competing requirements of the organization or business
Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
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