Staff Regulatory Specialist
2 months ago
What you need:
- 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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