Global Regulatory Affairs Specialist - Flexible Hours

Indero; Montreal; Híbrido; CAD 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working hours

Permanent full-time position

Comprehensive benefits

Descripción de la vacante

Innovaderm in Montreal is seeking a Regulatory Affairs Specialist to oversee EC, RA submissions and ensure regulatory compliance across CROs and partners. You will lead start-up activities for clinical trials and coordinate timelines with internal and external stakeholders.

The ideal candidate has 2–3 years CRO/Pharma regulatory experience with Health Canada and FDA, hands-on CTA and EC package readiness, and fluent English; French is a plus.

Formación

• Bachelor's degree in a scientific discipline.
• 2–3 years of CRO/Pharma regulatory experience with Health Canada and FDA.
• Hands-on experience preparing and submitting CTA and EC dossiers.

Responsabilidades

• Coordinate regulatory timelines for RA and EC submissions.
• Review regulatory documents produced by CROs/vendors for quality.
• Prepare regulatory documents, CTA packages, and country submissions.
• Manage EC submissions and serve as contact for sponsors and local teams.
• Provide regulatory guidance and EU submission strategy as needed.
• Maintain knowledge of Health Canada, FDA, and EU regulations.
• Participate in kickoff meetings, audits, and project meetings.

Conocimientos

Regulatory knowledge

GCP & ICH

English fluency

Organizational skills

Communication skills

Educación

Bachelor's degree in a scientific discipline

Descripción del empleo

Innovaderm in Montreal is seeking a Regulatory Affairs Specialist to oversee EC, RA submissions and ensure regulatory compliance across CROs and partners. You will lead start-up activities for clinical trials and coordinate timelines with internal and external stakeholders.

The ideal candidate has 2–3 years CRO/Pharma regulatory experience with Health Canada and FDA, hands-on CTA and EC package readiness, and fluent English; French is a plus.