Remote Senior Regulatory Affairs Lead — EU Cannabis

Cronos Group

Canada

Remote

CAD 130,000 - 150,000

Full time

3 days ago
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Job summary

Cronos Group is seeking an experienced Regulatory Affairs professional to obtain and maintain regulatory authorizations for Canadian medical cannabis products in European markets. You will support EU-GMP readiness, MAAs, and national registrations, coordinating with Quality, Operations, and Legal to ensure compliant submissions.

This remote role requires travel across North America and Europe as needed. The candidate will have 6–10 years in pharma, biotech, or cannabis regulatory roles, with

Qualifications

  • Degree in pharmacy, life sciences, chemistry or related discipline.
  • 6–10 years’ experience in pharmaceuticals, biotechnology or cannabis regulatory roles.
  • Hands-on EU-GMP certification support and inspections experience.
  • Experience preparing MAAs or national product registrations in Europe.
  • Ability to work without harmonized precedent and cite primary sources.

Responsibilities

  • Provide reports to Head of Global Regulatory Affairs on regulatory activities.
  • Monitor legislation and maintain a regulatory register across jurisdictions.
  • Advise on market entry feasibility and regulatory requirements during development.
  • Prepare and manage national product registrations and MAAs for relevant markets.
  • Maintain compliance for site and product registrations post-approval.
  • Support regulatory inspections and host authorities; manage deficiency responses.
  • Review Product Development, Marketing and Quality documents for compliance.
  • Collaborate with internal teams to ensure timely submissions.
  • Manage trackers and plan activities to meet standards and requirements.

Skills

Regulatory affairs
EU-GMP
Stakeholder management
Technical writing
English proficiency

Education

Degree in pharmacy, life sciences, chemistry
Post-graduate regulatory affairs qualification

Tools

Microsoft Office
Regulatory submission portals

Job description

Cronos Group is seeking an experienced Regulatory Affairs professional to obtain and maintain regulatory authorizations for Canadian medical cannabis products in European markets. You will support EU-GMP readiness, MAAs, and national registrations, coordinating with Quality, Operations, and Legal to ensure compliant submissions.

This remote role requires travel across North America and Europe as needed. The candidate will have 6–10 years in pharma, biotech, or cannabis regulatory roles, with

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