Staff Regulatory Specialist

1 month ago


Gurugram, India ALTEN Full time

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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