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Global Regulatory Manager

Job Post Index 237486-Sy##
Location Lawrenceville, NJ
Description: Job Description
  • Driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of products.
  • Responsible for interactions with Country Regulatory managers/regional leads regarding product registrations.
  • Drives and support local projects and department related assignments.
  • Responsible to keep up to date with the regulatory environment within the industry.
  • Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates in RIM Veeva vault system
  • Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
  • Responsible for overall regulatory related topics for assigned products /therapeutic area.
  • Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
  • Manage, track, review regulatory deliverables from external partners in line with vendor manager.
Skills: Qualifications
  • Doctor of Pharmacy or equivalent
  • 2-4 years of relevant experience expected , especially in Intercontinental region
  • Demonstrated ability to break down complex, scientific content into logical components
  • Ability to write in a clear, concise, and persuasive manner
  • Strong project management skills
  • Highly proficient in the use of Microsoft Word and PowerPoint
  • Experience in International markets
  • Experience in Veeva system RIM

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