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: https://thecronosgroup.com/. 

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 EudraLex 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.

What you’ll be doing:

• 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 timeframes.

• 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, etc.) to support compliance and product launches.

• Interact with other departments for the timely launch of products, especially with respect to regulatory issues and to ensure the appropriate information is obtained for submissions.

• Manage, maintain and update trackers for various subject matters for the department.

• Plan, conduct, and manage the activities to ensure compliance with internal and external standards and requirements.

• Establish and maintain professional standards of communication with colleagues within and outside the organization.

• Perform other duties and special projects as assigned.

You’ll need to have:

• Degree in pharmacy, life sciences, chemistry, or a related discipline. Post-graduate regulatory affairs qualification is an asset.

• 6 - 10 years’ experience in the pharmaceuticals, biotechnology and/or cannabis regulatory role, with a meaningful portion in-house or at a consultancy serving European markets.

• Demonstrated hands-on experience supporting EU-GMP certification and inspections of manufacturing sites, ideally including third country (non-Europe) sites supplying into Europe, not general familiarity. Familiarity with German Bundesland-level competent authorities and the AMG and MedCanG framework is a strong plus.

• Direct experience preparing or managing marketing authorization applications (MAAs) and/or national product registrations in European markets, including the knowledge of the distinction between medicinal product pathways, pharmacy-compounded/magistral routes, and API/raw material regimes.

• Comfort operating without harmonized precedent, constructing defensible and sound regulatory interpretation in line with the applicable laws, regulations and guidance documents, including the discipline of citing primary sources rather than secondary summaries – especially in positions where guidance is silent or divergent.

• Practical understanding of mutual recognition agreements between the European countries and non-EU third country (e.g., Canada), and where cannabis falls outside their scope. Includes practical understanding of narcotics import and export permitting under the UN Single Convention as implemented in European markets.

• Strong verbal and written communication skills with the ability to convey regulatory assessments and translate regulatory constraints into commercially usable advice clearly to both technical and non-technical audiences, and presentation abilities to share information with diverse groups.

• Ability to adapt to a rapidly changing corporate focuses and industry dynamics, being flexible and efficient in the fast-paced industry environment.

• Well-versed in Microsoft Office (Word, PowerPoint, Excel) and familiarity with IT systems (e.g., electronic submission portals, data and document management systems).

• Excellent at working with internal and external stakeholders, driving decision-making and collaboration.

• Exceptional attention to detail with excellent time management skills.

• Professional written and spoken English. Additional working languages relevant to target markets are an asset.

Salary range: $130,000 - $150,000 CAD per year