IQVIA Hiring 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: Regulatory Affairs Officer.
Job Description
- 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 the area of expertise, as appropriate.
- Establishes relationships with many customers; may meet face to face without the rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
- Understands the Scope of Work, deliverables, and management of the 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 a 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.
- 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 the area of expertise, as appropriate.
- Establishes relationships with many customers; may meet face to face without the rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments.
- Understands the Scope of Work, deliverables, and management of the 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 a 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.
Candidate Profile
M. Pharm / M. Sc. Graduate with 2-5 years of experience in Regulatory Affairs
M. Pharm / M. Sc. Graduate with 2-5 years of experience in Regulatory Affairs
Additional Information
Qualification: M.Pharm, M.Sc
experience: 2-5 years
Location: Kochi, India
Industry Type : Pharma / Healthcare / Clinical research
End Date: 5th March 2020
Qualification: M.Pharm, M.Sc
experience: 2-5 years
Location: Kochi, India
Industry Type : Pharma / Healthcare / Clinical research
End Date: 5th March 2020
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