Regulatory Affairs Specialist – Canada

Job not on LinkedIn

🔥 21 hours ago

🇨🇦 Canada – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Oversee central Ethics Committee, Regulatory Authority, and other submissions to ensure regulatory compliance and contractual timelines • Provide leadership for assigned projects and activities leading to clinical trial start-up • Coordinate regulatory timelines and deadlines for assigned Regulatory Authority and Ethics Committee submissions • Oversee mainly North American submissions, with possible participation in EU and APAC submissions • Review regulatory documents and submissions prepared by subcontractors, partner CROs, and regulatory vendors • Prepare regulatory documents, Clinical Trial Application packages, and country submissions • Prepare, manage, and track Ethics Committee submissions • Serve as point of contact for sponsors, subcontractors, and local teams regarding study regulatory submissions • Prepare or review Patient Information Sheets and Informed Consent Forms • Prepare or review study-specific regulatory forms • Manage translation requests with vendors • Provide regulatory support, advice, submission strategies, and technical expertise to local project teams and internal/external customers • Maintain knowledge of Health Canada, FDA, and EU regulations • Participate in kick-off meetings, audits, and other project-related meetings

🎯 Requirements

• Bachelor's degree (or equivalent) in a scientific discipline • Minimum of 2-3 years of clinical research experience (in CRO or Pharma) working within Health Canada and FDA regulatory affairs and with Ethics Committee regulations • Experience in study start-up phase • Hands-on experience preparing, reviewing, and submitting Clinical Trial Applications and Ethics Committee packages • Excellent knowledge of applicable regional/national regulatory guidelines and regulations • Excellent knowledge of GCP and ICH standards • Fluency in English with excellent oral and written skills • Additional languages, such as French, are an asset • Excellent organization and communication skills and attention to detail • Ability to organize own work, prioritize assignments, and work under pressure • Ability to multitask • Ability to respect established timelines, expectations, priorities, and objectives • Legally authorized to work in Canada

🏖️ Benefits

• Flexible working hours • Permanent full-time position • Comprehensive benefits: medical, dental, vision care, RRSPs, vacation, personal days, virtual medical clinic, discounts on public transit, social activities • Ongoing training and development • Offices close to public transportation (Sherbrooke metro station or Saint-Laurent metro station) • Attractive advancement opportunities