Require Regulatory Affairs Specialist at IQVIA

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 Specialist

Job Description
This is an exciting opportunity to own projects and apply your subject matter knowledge and drive CMC projects to completion. This role will have full ownership of the internal and external teams to deliver excellent customer service and regulatory CMC expertise. Working directly with a large Pharmaceutical client you will be an integral member of their team, working closely with their leadership.

Essential Functions
• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• 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;
• Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
• 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 standard operating procedures, as assigned and appropriate;
• May prepare and deliver regulatory training to IQVIA small groups or individuals;
• Performs other tasks or assignments, as delegated by Regulatory management;

Candidate Profile
• Bachelor's Degree Degree in Life science or related discipline Req
• At least 3-4 years relevant experience
• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
• Possesses a specific regulatory or technical expertise;
• Good, solid interpersonal communication (oral and written) and organisation skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;

Additional Information
Qualification : Degree in Life science
experience : 3-4 years
Location : Bangalore, India
Industry Type : Pharma / Healthcare / Clinical research
Req Id : R1239952
End Date : 30th October, 2021