Regulatory Intelligence Subject Matter Expert
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
- 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.
- 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
- 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