Intern, Regulatory Affairs-Canada

Indero • Montreal, QC

11d

About The Position

The Intern, Regulatory Affairs will support the Regulatory Affairs team in the preparation, organization, and maintenance of regulatory documentation for clinical research studies. Indero, formerly known as Innovaderm, is a world-renowned expert and clinical research leader in dermatology with over two decades of experience across a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint. Indero is a dual-focus Contract Research Organization (CRO) for dermatology and rheumatology, boasting more than 25 years of experience in clinical research and trial delivery. Their full-service approach encompasses protocol design, patient recruitment, trial monitoring, and biometrics, providing biotech and pharmaceutical sponsors with a rigorous scientific foundation and tailored expertise to efficiently and effectively complete their studies. With capabilities spanning North America, Europe, Asia Pacific, and Latin America, extensive and growing relationships with investigators and patients, and a dedicated research clinic for designing and executing their own studies, Indero positions itself as an ideal CRO partner for global clinical needs. Indero is committed to providing equitable treatment and equal opportunity to all individuals, offering accommodations throughout the recruitment and selection process to applicants with disabilities upon request. Innovaderm only accepts applicants who can legally work in Canada.

Requirements

• Undergraduate student in Life or Biological Sciences
• Basic understanding of clinical trial research
• Fluency in English with professional oral and written skills, required.
• Attention to detail and accuracy in work
• Computer skills including proficiency in the use of Microsoft Word and Excel
• Respect established timelines, expectations, and priorities

Nice To Haves

• Additional languages represent an asset.

Responsibilities

• Support the maintenance of regulatory files, trackers, and document repositories in accordance with internal procedures and regulatory requirements.
• Contribute to the continuous improvement of regulatory processes and templates
• Perform literature searches or regulatory research as assigned
• Participate in the development of the regulatory intelligence database.
• Assist with uploading regulatory documents in the Sponsor electronic Trial Master File (TMF)
• Support the preparation of standard regulatory documents using existing templates.
• May participate in the development of Informed Consent Forms and regulatory/ethics submission documentation.
• Participate in other regulatory or administrative tasks as assigned by the Regulatory Affairs team

What This Job Offers

• Career Level: Intern