Regulatory Intelligence Subject Matter Expert – India

Celegence is looking for a Regulatory Intelligence SME to support both Regulatory Services and Technology Development for Regulatory Intelligence in Bangalore, India.

Roles & Responsibilities

  • Provide Regulatory Intelligence (RI) services, proactively monitor regulations across regions to advise companies on how to create successful submissions
  • Consult in the areas of regulatory strategy, submissions and operations
  • Act as a Regulatory Technology Product SME to guide strategy for Regulatory Intelligence platform development
  • Market research on competitor technologies related to Regulatory Intelligence capturing, storing and sharing
  • Review and conduct both primary and secondary research on global Regulatory requirements for specific product types for reports and input into technology platform
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Collect regulatory requirements for eCTD submissions, labeling, pharmacovigilance, publishing and change management (variations)
  • Establish process and ensure adherence to the process related to RI information collection, review, quality checks, publish summary reports and engage consulting for client specific projects
  • Ensures appropriate and adequate resource allocation and back-up roles for project continuity timely delivery
  • Quality delivery through a rigorous metrics-based approach
  • Ensure timelines are being met
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Review deliverables on a regular basis and ensure proper project execution and minimizes risk on project and products
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required.
  • Ensures appropriate and adequate resource allocation and back-up roles for project continuity timely delivery.
  • Assist and support internal audits performed by Client.
  • Set-up and maintain local SOP system describing all procedures and processes in order to ensure compliance and share with Client
  • Conduct quality control of performed regulatory work as part of the daily routine
  • On need basis work with Subject Matter Experts (SME) from global network for country specific submission related topics
  • Accountable for resource utilization, management, competency development and other KPI established for services unit as well as teams assigned
  • Support pre-sales and marketing initiatives to promote RI Solution
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

  • Bachelor Degree in Pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred.
  • RAC certification is a plus.
  • PMP or ITIL certification is a plus.

Experience:

  • Minimum 5-7 years of relevant experience
  • Experience in Regulatory Affairs, specifically in gathering or monitoring regulatory intelligence across countries and regions
  • Understanding of global regulations related to Pharmaceuticals, Medical Devices and Biologics
  • Experience in creating customer facing materials
  • Able to work independently and manage a team if required
  • Fluent in English

Skills and Competencies

Technical Skills

  • Project Management

Non Technical Skills

  • Good knowledge of strategy development and implementation techniques
  • Excellent Communication and Writing Skills
  • Customer Focused
  • Customer Focused
  • Drive to deliver high quality proposals to clients
  • Good Stakeholder management
  • Strong Project management and tracking
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Please make sure you have the relevant work visa prior to applying

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