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Gurgaon

    Staff Regulatory Specialist - Gurugram, India - ALTEN

    ALTEN
    ALTEN Gurugram, India

    Found in: Talent IN 2A C2 - 2 days ago

    Default job background
    Upper Management / Consulting
    Description

    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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