Regulatory Affairs Coordinator | 12-Month Contract - Leamington, ON
About Tilray Brands
Tilray is a leading global cannabis-lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is changing people's lives for the better – one person at a time – by inspiring and empowering the worldwide community to live their very best life by providing them with products that meet the needs of their mind, body, and soul and invoke a sense of wellbeing. Tilray’s mission is to be the trusted partner for its patients and consumers by providing them with a cultivated experience and health and wellbeing through high-quality, differentiated brands and innovative products. A pioneer in cannabis research, cultivation, and distribution, Tilray’s unprecedented production platform supports over 20 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and alcoholic beverages.
Looking to develop your career at the forefront of a rapidly expanding industry?
The Regulatory Affairs Coordinator is responsible for providing regulatory guidance for new development and business opportunities, leading regulatory activities for global core filing documents, supporting export/import related documentation and overseeing licence maintenance.
This is a 12-month contract position to cover a maternity leave.
Duties and Responsibilities
- Responsible for the assessment and support of regulatory strategy (importing and exporting) and documentation of Avanti’s portfolio, for both inter companies and external clients, ensuring successful planning and execution of the global regulatory filings, in collaboration with regulatory leaders in each jurisdiction
- Responsible for identifying regulatory risks and provide mitigations for global submission strategies and product/clinical development, working with the global teams and internal departments, to address their specific needs. Conduct risk assessments and recommendations for various regulatory scenarios
- Provide technical support and ensure compliance during the development and approval of products for all markets
- Ensure that strategic regulatory input is provided to key clinical development activities (documents, licensing and product development assessment)
- Supervise and approve labelling development for the international market
- Supervise regulatory maintenance (different type of submissions, post- approval, deficiency letter), follow-up of client´s inquiries and complaints
- Review and interpret international regulations to collaborate with new business development
- Source manufacturing documents and scientific data from various operational departments to assemble dossiers for registration, and reformat data and information to meet specific requirements of each jurisdiction
- Provide support to obtain import and export permits.
- Manage Health Canada (and other government agencies) reporting requirements and overseeing licence maintenance, compliance and renewal
- Supporting the Quality team during inspection by regulators
- Minimum B.Sc. in Pharmacy or in a related scientific field
- 1 - 3 years of experience in the Pharmaceutical/Cannabis Industry, with work function in Regulatory Affairs/Quality Assurance/Compliance
- Thorough knowledge of global regulatory guidelines and regulations (EMA, ICH, Health Canada, US FDA, ANVISA, INVIMA, ANMAT), and quality requirements (cGMP, cGLP, GPP, and GACP)
- Thorough knowledge with CMC submission and post-approval of pharmaceutical drugs in various markets (WHO, Europe, LatAm, Africa, and Asia)
- Leadership skills, including delegation, time management and work allocation
- Ability to think strategically, coordinating global activities and building a positive relationship with clients
- Negotiating skills and resourcefulness
- Business/financial management experience is an asset
- Excellent verbal and written communication skills
- Efficient use and knowledge of MS Word, Excel and Outlook
Tilray welcomes applications from all qualified individuals and is committed to employment equity and diversity in the workplace.
Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application.
Please note that Tilray does not authorize, engage, or sponsor any consultants, agencies or organizations that seek certain personal or financial information from you (e.g. passwords, login ids, credit card information). High Park does not charge any application, processing or onboarding fee at any stage of the recruitment or hiring process.
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