IQVIA stands as a global leader in clinical research services, offering unparalleled commercial insights and healthcare intelligence. Renowned for accelerating the development and commercialization of innovative medical treatments, IQVIA is committed to enhancing patient outcomes and population health worldwide. With a network that spans multiple industries, IQVIA provides comprehensive solutions that merge technology with expertise, creating intelligent connections to drive success. As a part of its continued growth, IQVIA is seeking talented professionals to join its team as a Regulatory Affairs Officer 2 in Bengaluru, Karnataka.
Responsibilities in Job
As a Regulatory Affairs Officer 2, you will play a critical role in the regulatory lifecycle management for globally approved products. Below is an overview of your key responsibilities:
- Coordination and Planning: Ensure that all regulatory lifecycle management activities and approvals are executed on time in collaboration with the Local Operating Company (LOC).
- Point of Contact: Act as the liaison for LOCs and stakeholders, providing guidance on changes, including Chemistry, Manufacturing, and Controls (CMC) and labeling-related modifications.
- Collaboration: Work closely with LOCs and relevant stakeholders to clarify regulatory requirements and prepare submission packages.
- Quality Assurance: Conduct quality control (QC) reviews for deliverables prepared by other GRLs and maintain compliance with IQVIA’s quality management system (QMS) procedures.
- Documentation and Submission: Prepare deliverables such as variations, renewals, supplements, and new marketing authorizations. Handle responses to health authority queries and contribute to core submission documentation.
- Regulatory Support: Offer regulatory insights for PSURs, PBRERs, and other risk management reports.
- US Regulatory Focus: Prepare and review FDA deficiency letters and responses, ensuring thorough support for annual report submissions to the FDA.
- Problem Resolution: Identify quality events and process deviations, providing solutions to improve job effectiveness.
- Process Adherence: Operate consistently within established standard operating procedures (SOPs) and contribute independent thought to optimize processes.
Qualifications
To excel in this role, you should meet the following qualifications:
- Educational Background: A Bachelor’s or Master’s degree in Life Sciences or a related field.
- Experience: 3-4 years of relevant experience in regulatory affairs.
- Knowledge Base: A solid understanding of the Research and Development process, including CMC, preclinical, and clinical processes.
- Regulatory Expertise: Possesses specialized regulatory or technical knowledge, allowing for effective contribution to complex projects.
- Decision-Making Skills: Ability to make informed decisions on discrete tasks under supervision.
- Problem-Solving: Capable of addressing general issues that may require understanding a broader set of problems.
- Adaptability: Ability to thrive in a rapidly changing environment.
Essential Skills
Successful candidates for the Regulatory Affairs Officer 2 position should demonstrate:
- Communication Skills: Strong oral and written communication for effective collaboration.
- Organizational Skills: Ability to manage multiple projects and adhere to deadlines.
- Technical Proficiency: Familiarity with Microsoft Office and publishing tools.
- Interpersonal Skills: Ability to establish effective working relationships with teams and stakeholders.
- Self-Motivation: Demonstrates enthusiasm and a proactive approach to work.
- Process Improvement: Provides independent input to enhance existing processes.
