IQVIA is looking for a dedicated and detail-oriented Senior Regulatory Affairs Officer to join our Regulatory Affairs team. In this role, you will support the preparation and review of regulatory submission documents for clinical trials and marketing authorizations, working closely with both internal teams and external clients.
Please note:
Experience working in the eCTD format and PDF publishing in accordance with ICH standards are mandatory requirements for this position.
Responsibilities
- Act as a Regulatory Team Member on small, straightforward projects or single-service assignments under the guidance of senior staff.
- Identify project needs, manage timelines, and implement client requests in collaboration with team members.
- Apply regulatory knowledge in areas such as: Chemistry, Manufacturing and Controls (CMC), Lifecycle Maintenance, Marketing Authorization Transfers, Labeling and Publishing.
- Prepare and review regulatory documentation in your area of expertise.
Required Qualifications
- Bachelor’s or Master’s degree in Life Sciences or a related discipline.
- Minimum of 2 years of relevant experience in regulatory affairs. Proven experience with: eCTD format submissions and PDF publishing aligned with ICH standards.
Key Skills
- Solid understanding of the R&D process (CMC, Preclinical, Clinical) and relevant regulatory guidelines.
- Strong communication and organizational skills.
- Proficiency in Microsoft Office and regulatory publishing tools.
- Ability to manage multiple projects with guidance from senior staff.
- Team-oriented with the ability to build effective working relationships.
Why Join IQVIA?
At IQVIA, you’ll be part of a global team that’s driving healthcare forward. We offer a collaborative environment, opportunities for growth, and the chance to work on impactful projects that shape the future of medicine.
Ready to make a difference?
Apply now and help us improve patient outcomes worldwide.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com
