Regulatory Affairs Specialist/Spécialiste affaires réglementaires

at  Innovaderm Research

Due to ongoing global expansion, Innovaderm is looking to hire a Regulatory Affairs Specialist. In this position, you will be responsible for overseeing central Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and guidance documents and contractual timelines are met. You will provide leadership for assigned projects regarding all activities that lead to start up of clinical trials.

This role will be perfect for you if:

• You approach challenges with an understanding of standards and regulations, combined with a creative and inquisitive mind.
• You enjoy working as part of a small team. You enjoy using your experience and expertise to accomplish a variety of tasks.
• You thrive in using your expertise supporting, advising and providing strategies and technical expertise on regulatory documents.

EDUCATION

• Bachelor’s degree (or equivalent) in a scientific discipline

EXPERIENCE

• 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 ( EC) regulations is required
• Experience in study start-up phase is essential
• Hands-on experience preparing, reviewing, and submitting Clinical Trial Applications and EC packages.

KNOWLEDGE AND SKILLS

• Excellent knowledge of applicable regional / national country regulatory guidelines and regulations
• Excellent knowledge of GCP and ICH standards
• Fluency in English with excellent oral and written skills, required
• Additional languages, such as French, represent an asset
• Excellent organization and communication skills, great attention to detail
• Ability to organize own work, prioritize different assignments, and work under pressure;
• Versatile and comfortable in a multitasking environment;
• Respect established timelines, expectations, priorities, and objectives;
  Our company:

RESPONSIBILITIES:

• Coordination of regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Includes oversight of North America (mainly) submissions and may include participation in EU, and APAC submissions.
• Review of regulatory documents and submissions created outside of the company by subcontractors (eg, partner CROs, regulatory vendors) to ensure high quality standards before submission to RA / EC
• Preparation of regulatory documents and CTA packages, and submissions in assigned countries to ensure high quality standards
• Preparation, management, and tracking of EC submissions to ensure high quality standards
• Point of contact for Sponsors and subcontractors/local teams for all aspects related to study regulatory submissions
• Preparation or review of Master and country specific Patient Information Sheet/Informed Consent form documents.
• Preparation or review of study-specific regulatory forms.
• Manages translation requests with vendor.
• Regulatory support and advice to local project teams and key internal/external customers; provide project specific local EU submission strategy and technical expertise
• Maintain high level knowledge about Health Canada, FDA, and EU regulations in the area of company interest
• Participation in Kick-off meetings, audits, and other project related meetings according to the company / client needs
  Requirements:

This role will be perfect for you if:

• You approach challenges with an understanding of standards and regulations, combined with a creative and inquisitive mind.
• You enjoy working as part of a small team. You enjoy using your experience and expertise to accomplish a variety of tasks.
• You thrive in using your expertise supporting, advising and providing strategies and technical expertise on regulatory documents