Reg Affairs Officer 1 (R1117421) in Kochi, India at IQVIA™

Date Posted: 2/5/2020

Job Snapshot

  • Employee Type:
  • Location:
    Kochi, India
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

An M. Pharm/ M. Sc. Graduate with 2-5 years of experience in Regulatory Affairs
- May act as a Regulatory Team Leader on more complex projects, which may include technical writing. 
- Should have knowledge on Regulatory requirements/ CMC/ Lifecycle maintenance/ Marketing Authorization Transfers
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate. 
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments. 
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate. 
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development. 
- May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person. 
- May act as reviewer for regulatory SOPs, as assigned and appropriate. 
- May prepare and deliver regulatory training to Quintiles small groups or individuals. 
- Performs other tasks or assignments, as delegated by Regulatory management.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1117421