Job Description
Education
- Bachelor’s degree in life sciences, Regulatory Affairs, or a related discipline required.
Experience
- 2–5 years of experience in Regulatory Affairs
- Experience supporting electronic regulatory submissions and document preparation in a regulated environment preferred.
- Familiarity with eCTD structure, publishing processes, and submission-ready document requirements preferred.
Required Skills and Competencies
- Strong organizational skills and the ability to manage multiple tasks and deadlines simultaneously.
- Excellent attention to detail and commitment to document quality and accuracy.
- Understanding of regulatory submission processes and document lifecycle management.
- Ability to work effectively in a cross-functional, fast-paced environment.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint. Proficiency in Veeva RIM preferred.
- Ability to identify issues proactively and support timely resolution.
- Demonstrated ability to maintain confidentiality and handle sensitive documentation appropriately.