Regulatory Operations Associate

Celegence is looking for an experienced Regulatory Operations Associate to deliver on Regulatory Affairs operational projects in Bangalore, India. This includes a Regulatory Submissions Management specialist who will be responsible for the publishing and dispatch of basic and complex lifecycle management eCTD submissions and ensuring technical validation. Additionally, the associate should have a working knowledge of internal/external publishing standards, electronic publishing/viewing software tools and document management systems. This individual will independently perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents.

Roles & Responsibilities

  • Publish and dispatch complex routine/lifecycle management eCTD submission projects
  • Perform document level publishing activities, troubleshoot document issues and perform quality control checks for submission ready documents
  • Collaborate with scientific personnel for planning, preparation, publishing and quality control checks of submissions.
  • Participate in Global Regulatory Affairs project teams
  • Maintain working knowledge of internal and external publishing standards
  • Identifies incorrect, incomplete, or date that requires verification.
  • Understands the business benefit and risk to steps being performed.
  • Performs tasks with care, focusing on accuracy and efficiency
  • Identifies existing problems/process inefficiencies and has novel approaches to solving those problems.
  • Contributes original and resourceful ideas in brainstorming sessions.
  • Can describe customers’ business and expectations, as well as anticipates, and responds timely to customer needs.

Education & Experience

  • Required: Bachelor’s Degree in Life Sciences or Information Technology
  • Experience Required: 3-5 years in Regulatory Operations/Regulatory Affairs. Experience as a publisher for regulatory applications a plus

Skills and Competencies

Technical Skill

  • Experience with eCTD technologies, Microsoft Office, Adobe Acrobat. Liquent Insight a plus.
  • Basic understanding of IT infrastructure.
  • Understanding of the drug development process. Knowledge of generics and branded product development a plus.
  • Working knowledge of industry legislation and best practices.
  • Knowledge of regulations/guidelines governing regulatory submissions.

Non Technical Skills

  • Hands on person with problem-solving attitude
  • Strong verbal and written communication skills in English, ability to influence others, and strategic thinking
  • Customer focused
  • Organized, thoughtful, and positive

Apply


upload your resume*

Request Information
close slider