Senior Manager, Regulatory Affairs - Europe

Cronos is an innovative global cannabinoid company committed to building disruptive intellectual property by advancing cannabis research, technology, and product development. With a passion to responsibly elevate the consumer experience, Cronos is building an iconic brand portfolio. Cronos’ diverse international brand portfolio includes Spinach®, PEACE NATURALS® and Lord Jones®. For more information about Cronos and its brands, please visit:

At Cronos Group, we hire talented people who thrive on solving difficult problems and give them the opportunity to hone new skills and approaches. If you want to play a part in shaping an innovative industry and help build a historically significant company, we want to meet you.

This role will be responsible for obtaining and maintaining the regulatory authorizations that will permit Cronos Group’s Canadian-manufactured medical cannabis products to be imported, released, and supplied in European markets, and for supporting commercial growth in those markets. Core activities include EU-GMP inspection readiness and certification maintenance for third-country manufacturing sites, narcotics import and export permitting, national product registrations and, where applicable, marketing authorization applications, and regulatory intelligence across target markets.

The role operates across three regimes that must be managed together:
European pharmaceutical law (Directive 2001/83/EC and Eudra Lex Volume
4), the international controlled-substances framework (Single Convention on Narcotic Drugs, 1961), and divergent national cannabis frameworks that are not harmonized at EU level.

This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents for the regulatory applications. Professional links need to be established with all internal departments involved e.g., Quality, Operations, Supply Chain, Research & Development, Product Development, Legal, Sales, and Marketing, and specifically all external partners to ensure applications, registrations, and permits are prepared, compiled, and maintained in compliance with the regulations and are submitted and approved in an efficient and timely manner.

This is a remote position, but the ability to travel across North America and Europe is as required based on business needs.

• Provide timely and appropriate reports to the Head of Global Regulatory Affairs.

• Monitor and keep abreast of legislation, regulations, and guidance, document changes and maintain a regulatory register across multiple jurisdictions.

• Provide strategic regulatory insight and advise commercial teams on market entry feasibility and on product regulatory requirements during development and throughout life cycle management.

• Advise on the content and format requirements for regulatory documents for all products and site licenses and registrations.

• Prepare and manage high quality national product registrations, notifications, and where applicable, marketing authorization applications (MAAs) (i.e., registration, amendments, and renewals or similar) for direct submission and/or for indirect submission to the competent authorities via external partners for the relevant markets within scheduled time frames.

• Maintain regulatory compliance for the site and product registrations once approvals have been obtained.

• Provide support for regulatory inspections including pre-inspection readiness, hosting competent authority inspectors, deficiency responses, and maintaining GMP certification.

• Review and approve all relevant Product Development, Marketing, and Quality Management Documents (e.g., product labels, promotional and advertising materials, study protocols and reports, change controls, deviations, complaints,…