Regulatory Affairs Manager

**Regulatory Affairs Manager**

**CANTANHEDE - PORTUGAL**

Tilray Brands 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?**

As
**Regulatory Affairs Manager **you will be responsible for participation in and delivery of activities aimed at obtaining and maintaining drug marketing authorizations (compilation of sections of registration documentation and registration dossiers) in accordance with the law, internal regulations, Good Practices, and business objectives.

**Role and Responsibilities**
- Assess and stay up-to-date on regulatory requirements for medical cannabis products in new and existing markets to ensure Tilray’s product quality standards meet regulatory requirements in every market
- Evaluate all feasible pathways for product registration via medical cannabis-specific regulatory frameworks
- Manage the preparation of regulatory submissions, including assembly and proper formatting of product manufacturing data and preclinical/clinical data
- Define and maintain systematic collation procedures for product quality documentation in the Controlled Document Library in accordance with document control procedures
- Perform regular impact assessment reports of any regulatory changes to ensure continuous compliance with applicable regulations
- Review product labels and other required product documentation to ensure compliance

**Qualifications**
- University degree in chemistry, pharmacy, or other equivalent degrees
- 5 years of relevant experience within a Quality Assurance GMP environment within the Pharmaceutical/Chemical Industry
- Previous experience (minimum 2 years) in operational areas such as Manufacturing, R&D, or QC
- Experience interacting with health regulatory agencies, preferably with international experience
- Experience in leading others and managing teams
- Willingness to cooperate and communicate openly with internal or external partners
- Goal-oriented behavior, good interpersonal and communicational skills
- Positive attitude, willingness to cooperate, and open communication
- Fluency in English
- German language is a plus