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
- 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