IQVIA Hiring Regulatory Affairs Specialist in Clinical Operations

IQVIA is Hiring: Join as a Regulatory Affairs Specialist in Clinical Operations

Are you an experienced professional in regulatory affairs within the pharmaceutical industry? IQVIA is offering an exciting opportunity for a Regulatory Affairs Specialist in Clinical Operations at their Bengaluru, Karnataka location. If you’re looking for a rewarding career in regulatory affairs, read on to learn more about this opportunity.

About IQVIA

IQVIA is a global leader in providing advanced analytics, technology solutions, and contract research services to the life sciences industry. With a commitment to improving healthcare outcomes, IQVIA plays a pivotal role in advancing medical research and innovation.

Position: Regulatory Affairs Specialist

Category: Clinical Operations

Location: Bengaluru, Karnataka

Job Type: Full-Time

Referred By: Niranjan M

Job Description

As a Regulatory Affairs Specialist at IQVIA, you will have a significant role in ensuring regulatory compliance and managing submission-related activities. Your key responsibilities will include:

• Serving as a Submission or eCTD Publisher/Co-ordinator on complex projects, providing strategic solutions for submissions.
• Creating, assembling, and publishing both major and routine global paper and electronic submissions, such as NDAs, INDs, 510(k)s, Annual Reports, and more.
• Expertise in Document Publishing activity using Publishing ToolBox Plug-In for Clinical and Non-Clinical Documents.
• Understanding overall project management activities within publishing or submissions.
• Acting as a Subject Matter Expert or Project Manager on publishing projects, providing strategic regulatory or technical consultancy.
• Delivering business development presentations to customers and contributing to submission publishing proposals.
• Ensuring compliance with regulatory processes and readiness for project audits.
• Collaborating with functional areas to ensure compliant documents and providing resolutions to regulatory and company guidance/template specifications.
• Planning, preparing, and tracking regulatory publishing and submission projects, including revenue and budget monitoring.
• Maintaining knowledge of regulations and processes governing controlled documents.
• Representing on project team meetings, driving timelines and deliverables.
• Strong Technical knowledge of electronic publishing systems and software.
• Self-starter with excellent time management skills and ability to work independently or in teams.
• Designing training materials and delivering training internally and externally.
• Contributing to the update of SOPs, Work Instructions, and Checklists.

Qualifications

• Bachelor’s Degree or Master’s Degree in Lifescience or related discipline.
• 6 to 8 years of relevant experience in regulatory affairs.
• Good understanding of the Research and Development process.
• Strong interpersonal communication and organizational skills.
• Proficiency in Microsoft Office and publishing applications.
• Self-motivated and enthusiastic.
• Ability to work on multiple projects with direction.
• Ability to follow standard operating procedures consistently.
• Ability to adapt to a changing environment.
• Applicable certifications and licenses as required.

Why Choose IQVIA?

• Global Impact: Be part of a company that’s driving advancements in the pharmaceutical and life sciences industry.
• Cutting-Edge Work: Contribute to cutting-edge research and regulatory compliance.
• Professional Growth: Join a team that values your expertise and offers opportunities for growth.

Apply online