IQVIA Life Sciences Reg Affairs Officer Recruitment – Apply Online
IQVIA Life Sciences Reg Affairs Officer Recruitment – Apply Online. IQVIA Life Sciences Reg Affairs Officer 2 Job. For more details on the Job description, responsibilities and such, check out all the details posted below.
Job Title: Reg Affairs Officer 2
Primary Location: Bangalore, India
Job ID: R1219006
JOB DESCRIPTION
Background and Domain Expertise :
- Degree, life sciences
- Supplementary experience or education with a regulatory component (e.g. RAPS RA certificate/certification)
- Language skills (English)
- Experience in the industry gained at a regional/local level and knowledge of the requirements/practical experience across one or more regulatory domains for drugs/medical devices or both.
- Knowledge of local regional/country regulations and local practices for the relevant regulatory domain(s) – see list of countries
- Awareness of regional/local industry hot topics and trend
Content Maintenance
- Identify and conduct regional/local horizon scanning activities, e.g. by monitoring useful sources of information not covered in the standard Reference Document Monitoring process (e.g. webinars, blogs, newsletters, local forums, blogs, networks, journals, conferences/workshops, trade associations, newsletters).
- Anticipate, interpret and assess the impact of regulatory developments (guidelines, regulations and laws) and apply to content
- Interpret regional/local regulations and guidelines and provide clear and accurate responses (Cross Country Tables (CCT) and Expert Summary (ES) content)
- Responsible for accurate and timely updates of CCTs and ES.
- Provide clarification or corrections to responses based on QC review.
- Raise queries to the Local Regulatory Authority to obtain clarification, where needed.
Service Knowledge/Customer support
- Build and maintain in-depth knowledge of the Tarius database content and scope (Ref Docs, CCTs, ES) for relevant region/countries.
- Support enquiries from customers, sales, marketing and business development – provide input on regional/local requirements (as requested by Global SME) in a complete and timely manner
IT skills
- Intermediate skills – word, excel, PowerPoint
- Tarius database – understanding of metadata, search functionality and back-end process for CCTs ES, Ref Docs and Newsletters
- Perform updates in CCT Editor (CCT) and Box.com (ES).
- Service Cloud Database
Content Maintenance
Review meeting materials/attend meetings and prepare the following reports:
- Background Analysis – clinical and regulatory background
- Briefing Summary – from FDA and sponsor briefing materials
- Results Wire – key outcomes of meeting
- Final Results Wire – individual member votes and comments
- FDA decision report – summary of FDA decision
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