Regulatory Affairs Specialist, CMC Home based Europe

 Regulatory Affairs Specialist, CMC Home based (Europe)   

IQVIA,
Bengaluru, Karnataka, India (Remote)

Full-time
10,001+ employees · Hospital & Health Care

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.

Qualifications

•  Bachelor's Degree Degree in Lifescience or related discipline Required
• 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.

Apply Now

View company: IQVIA

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.