IQVIA looking for Regulatory Affairs Officer
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.
Post : Reg Affairs Officer
- 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.
M. Pharm / M. Sc. Graduate with 2-5 years of experience in Regulatory Affairs
Qualification : M.Pharm, M.Sc
experience : 2-5 years
Location : Kochi, India
Industry Type : Pharma / Healthcare / Clinical research
Req Id : R1117421
End Date : 5th March, 2020
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