Regulatory Affairs Associate

Regulatory Affairs Associate

Indero (formerly Innovaderm) is seeking a detail-oriented Regulatory Affairs Associate to support the preparation, tracking, and coordination of Ethics Committee (EC) and Regulatory Authority (RA) submissions. This role involves ensuring clinical trial submissions comply with regulations and internal timelines under supervision.

Key Responsibilities:

• Assist in compiling and preparing documentation for EC and RA submissions.
• Support the tracking of submission timelines and maintain regulatory trackers/databases.
• Aid in preparing and submitting initial applications, amendments, and notifications.
• Coordinate with IRB/IEC and internal teams for required documentation.
• Review and format documents for consistency and completeness before submission.
• Assist in adapting country-specific informed consent forms from master templates.
• Coordinate translation requests and track vendor deliverables.
• Submit documents to the Trial Master File (TMF) and participate in TMF reconciliation.
• Perform administrative tasks including archiving, status reporting, and follow-ups.
• Support regulatory specialists in reviewing and submitting SUSARs as needed.
• Stay informed of basic regulatory guidelines for assigned countries.
• Participate in internal meetings and training sessions.

Requirements:

• Bachelor’s degree (or equivalent) in a scientific discipline.
• 0-2 years of experience in clinical regulatory affairs within the pharmaceutical, biotechnology, or CRO industry.
• Experience preparing and submitting IRB/IEC packages and/or CTAs.
• Knowledge of applicable regional/national regulatory guidelines and IRB/IEC regulations is an asset.
• Excellent knowledge of Microsoft Office Suite (Word, Excel, Outlook).
• Fluency in English (oral and written); additional languages are an asset.
• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Willingness to learn and develop regulatory expertise under guidance.

The Work Environment:

Join a team of brilliant and driven colleagues at Indero, where our values are collaboration, innovation, reliability, and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

Perks:

• Permanent full-time position
• Flexible schedule
• Vacation
• Home-based position
• Ongoing learning and development

About Indero:

Indero, formerly Innovaderm, is a globally recognized leader in dermatology clinical research with over two decades of experience. As a dual-focus CRO for dermatology and rheumatology, we offer a full-service approach from protocol design to trial monitoring, serving biotech and pharmaceutical sponsors worldwide. Our capabilities span North America, Europe, Asia Pacific, and Latin America, supported by strong investigator and patient relationships, and our own dedicated research clinic.

Key Skills/Competency:

• Regulatory Affairs
• Clinical Trials
• Ethics Committee Submissions
• Regulatory Authority Submissions
• Documentation Management
• TMF Management
• CRO Industry
• Pharmaceutical Industry
• Biotechnology Industry
• Attention to Detail