Director, Regulatory Affairs

Employer
Cybin
Location
Working from home
Posted
Oct 07, 2021
Required Education
Bachelors Degree
Position Type
Full time

Cybin has an exciting opportunity to join the growing team!

A leading biotechnology company, Cybin is focused on and dedicated to progressing psychedelic therapeutics by utilizing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches, and treatment regimens for psychiatric disorders. To learn more about Cybin, visit https://www.cybin.com.

ABOUT THE POSITION

Reporting to the Chief Operating Officer, the Director of Regulatory Affairs develops innovative regulatory strategies for Cybins innovative pipeline of psychedelic therapies. The Director of Regulatory Affairs initiates the development and execution of regulatory strategies for clinical-phase, psychiatric therapies with internal partners and external consultants. The Director of Regulatory Affairs serves as the primary point of contact with Global Health Authorities and positions Cybin for optimal regulatory outcomes.

RESPONSIBILITIES
  • Actively contributes to the development and execution of global regulatory strategies for R&D.
  • Works with cross-functional team members to identify, assess and communicate regulatory risks and recommends solutions to senior management.
  • Interacts with project team members to ensure high quality and timely regulatory submissions.
  • Ensures all national registrations, licenses, listings, and other certifications are maintained as required for regulatory compliance.
  • Conducts and analyzes regulatory research providing guidance to the business and project teams on competitive landscape and regulatory intelligence.
  • Selects and effectively manages external regulatory consultants.
REQUIREMENTS
  • Bachelor's Degree in a technical, scientific, or health discipline
  • Minimum of 10 years relevant regulatory experience
  • Direct experience with development, preparation, and submission of CTAs/INDs/NDAs and with regulatory agencies
  • Strong knowledge of FDA and EMA regulations, GCP, GMP, and ICH guidelines
  • Experience with regulatory/compliance in pre-clinical, clinical, and manufacturing
  • Demonstrated organizational skills, ability to independently prioritize work, and detail-oriented
  • Strong verbal and written communication skills
  • Sound technical judgment, discretion, and critical thinking skills to make informed decisions
  • Proficient in MS Office applications
EQUAL OPPORTUNITY

Cybin Inc. is an Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to ethnicity, color, national origin, age, religion, sexual orientation, gender identity or expression, family or parental status, veteran status, neurodiversity status, disability status, or any other basis protected by applicable law. We are proud to provide employment accommodation during the recruitment process. Should you require accommodation, please contact us at HR@cybin.com and we will work with you to meet your accessibility needs. We appreciate all applications however, only those candidates selected for an interview will be contacted.