Regulatory Affairs OfficerIQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence, serving the life sciences and healthcare industries. With a mission to accelerate the development and commercialization of innovative medical treatments, IQVIA helps improve patient outcomes and global population health. The company leverages data-driven insights and advanced technologies to deliver impactful solutions in research and development, clinical trials, and regulatory compliance. Learn more at IQVIA Careers.
Job Responsibilities: As a Regulatory Affairs Officer in IQVIA’s Clinical Operations team in Bengaluru, your key responsibilities will include:
- Preparing and/or reviewing regulatory submission documents to support clinical trials and marketing authorization activities.
- Acting as a regulatory team member on small, straightforward projects, working under the guidance of senior staff.
- Managing project timelines, tracking needs, and implementing client requests in collaboration with senior management.
- Preparing regulatory documentation, especially in areas such as Chemistry, Manufacturing, and Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, Labeling, and Publishing.
- Participating in project teams with both internal and external customers and confidently handling communications on regulatory matters.
- Preparing materials for business development meetings and delivering presentations under senior guidance.
- Contributing to process improvements by following standard operating procedures and making minor adjustments to systems as necessary.
Qualifications: To be eligible for this role, candidates must have:
- A Bachelor’s or Master’s degree in Life Sciences or a related field.
- At least 2 years of relevant experience in regulatory affairs.
- A solid understanding of the Research and Development process, including Chemistry, Manufacturing & Controls, Preclinical, and Clinical procedures.
- Knowledge of relevant laws and regulatory guidelines applicable to the pharmaceutical industry.
- Good interpersonal and communication skills (oral and written).
- Strong organization skills and the ability to manage multiple tasks effectively.
Skills Required:
- Advanced regulatory knowledge in CMC, lifecycle maintenance, and marketing authorization processes.
- Proficiency in Microsoft Office and other publishing tools used in regulatory documentation.
- Ability to work independently and manage minor adjustments in systems and processes.
- Enthusiasm and self-motivation, with a capacity to follow procedures consistently and contribute to process improvements.
