Regulatory Specialist - Dusseldorf, Germany
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
Looking to develop your career at the forefront of a rapidly expanding industry?
Ready to apply your talents to make a positive difference in the lives of patients across the country?
Reporting to the VP, Regulatory and Medical Affairs, the Regulatory Specialist will be responsible for interacting with regulatory agencies on medical cannabis regulations throughout the EU. The incumbent assesses and thoroughly understands the evolving regulatory landscape, develops strategies for product registration. Ensures that the quality departments understand and maintain product documentation required for regulatory compliance. The incumbent is also responsible for drafting, compiling and controlling product development documentation to support international Product Registration and Market Launch initiatives. The ideal candidate is highly organized, has good regulatory strategic thinking, can adapt to changing priorities and demonstrates good communication, project management and problem-solving skills.
Role and Responsibilities
- Assess regulatory environments and requirements of existing and new jurisdictions and markets to ensure product quality documentation is maintained throughout the entire product life cycle
- Generate accurate and up-to-date product quality documents, compliant with EMA regulations
- Work closely and collaboratively with the Quality Team to ensure that all product quality documentation has the applicable data set for compliance
- Understand and evaluate each market’s medical cannabis regulations to ensure that product quality documents for each market are compliant with regulations in that market
- Understand and evaluate each market’s medical cannabis regulations to develop innovative strategies for product registrations
- Harmonize product quality documents where possible, considering differences in regulations between markets
- Ensure that scientific data supporting submissions comply with applicable national and international regulations and guidelines
- Assemble and maintain product quality documentation in the Document Library in accordance with document control procedures
- Provide GMP-related regulatory advice to other departments (Facilities, Procurement, Manufacturing, Logistics, etc.) and advise on incorporating regulatory requirements into QMS documentation.
- Perform internal departmental regulatory compliance audits to facilitate sustained conformance
- Review product labels or other required documentation to ensure compliance with International requirements
- B.Sc. degree in Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training
- Post-Graduate Regulatory Certification preferred
- 7 years’ experience working within a pharmaceutical manufacturing, packaging, and/or warehousing with cGMP-compliant Quality Management System
- Strong understanding of regulatory requirements for movement of controlled/uncontrolled drug products between different jurisdictions
- Thorough knowledge of EMA regulations related to product quality (GMP, GACP, GPP) as well as ability to interpret changing policies and guidelines
- Strong understanding of product quality data generation, particularly for GMP compliance and Chemistry, Manufacturing and Controls (CMC) sections
- Proven ability to generate a variety of technical product quality documentation
- Experience maintaining quality management systems and programs (ISO9001, GMP, HACCP) preferred
- Proficiency in English and Portuguese; Some knowledge of German and Spanish preferred
- Willing to travel, approx. 20%