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.

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 / ECPreparation of regulatory documents and CTA packages, and submissions in assigned countries to ensure high quality standardsPreparation, management, and tracking of EC submissions to ensure high quality standardsPoint of contact for Sponsors and subcontractors/local teams for all aspects related to study regulatory submissionsPreparation 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 expertiseMaintain high level knowledge about Health Canada, FDA, and EU regulations in the area of company interestParticipation in Kick-off meetings, audits, and other project related meetings according to the company / client needsRequirements:EducationBachelor's degree (or equivalent) in a scientific disciplineExperienceMinimum 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 requiredExperience in study start-up phase is essentialHands-on experience preparing, reviewing, and submitting Clinical Trial Applications and EC packages.
Knowledge and skillsExcellent knowledge of applicable regional / national country regulatory guidelines and regulationsExcellent knowledge of GCP and ICH standardsFluency in English with excellent oral and written skills, requiredAdditional languages, such as French, represent an assetExcellent organization and communication skills, great attention to detailAbility 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;Brand name:InderoOur company:The work environmentAt Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness.

We offer
a stimulating work environment and attractive advancement opportunities.
As a Regulatory Affairs Specialist you will be eligible for the following perks:Flexible

working hours
Permanent full time positionComprehensive benefits (medical, dental, vision care, RRSPs, vacation, personal days, virtual medical clinic, discounts on public transit, social activities)Offices close to public transportation (Sherbrooke metro station or Saint-Laurent metro station)Ongoing training and developmentAbout InnovadermInnovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Canada.
Description de poste:En raison de son expansion mondiale, Innovaderm cherche à recruter un spécialiste des affaires réglementaires. Dans le cadre de ce poste, vous serez chargé de superviser le comité d'éthique (CE) ,l'autorité réglementaire (AR) et d'autres soumissions créées au sein ou à l'extérieur de l'entreprise afin de garantir que les soumissions sont con

📌 Regulatory Affairs Specialist/Spécialiste affaires réglementaires-Canada (Montreal)
🏢 Indero
📍 Montreal