Indero is a world-renowned clinical research leader in dermatology and rheumatology, providing full-service support to biotech and pharmaceutical sponsors globally. We are currently seeking a dedicated Regulatory Affairs Associate to join our team and support the preparation, tracking, and coordination of Ethics Committee and Regulatory Authority submissions.
Key responsibilities
- Assist in the compilation and preparation of documentation required for EC and RA submissions.
- Support the tracking of submission timelines and maintain up-to-date regulatory trackers and databases.
- Review and format documents for consistency and completeness prior to submission.
- Coordinate translation requests and track deliverables from external vendors.
- Help submit documents to the Trial Master File and participate in reconciliation activities.
Requirements
- Bachelor’s degree in a scientific discipline.
- 0-2 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
- Fluency in English, with strong attention to detail and organizational skills.
- Proficiency in the Microsoft Office suite.
- Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
What we offer
- Permanent full-time position.
- Flexible schedule and a fully remote work environment.
- Ongoing learning and development opportunities.
- Vacation benefits.