Director Quality Assurance Regulatory Affairs

We are excited to announce the opening for the position of Cybins Quality Assurance and Regulatory Affairs. The incumbent must have knowledge of FDA requirements for Clinical Trials, Health Canada and CMC submissions.

The Quality Affairs (QA) & Regulatory Affairs(RA) person will be responsible for all QA & RA functions including, but not limited to supplier/vendor audits, batch/lot record review and release, raw data review, deviation/failure investigation, change evaluation, product sampling, and retention as it relates to Drugs, Natural Health Products, Medical Devices and Cosmetics that are imported and/or distributed by the company in United States and Globally.

·     Conduct a review of and track Good Manufacturing Practices (GMP) documentation, including Master Batch Records, Master Packaging Records, Certificates of Analysis, Annual Product Quality Reviews, Stability, etc., for products imported and marketed.

What will you be doing?

• Manage, create, and coordinate Regulatory and CMC submission documents for early phase clinical submissions through to marketing applications.
• Manage the planning, preparation, and review of high-quality Regulatory responses to US, EU and Global queries for assigned projects
• Support the planning, tracking and execution of deliverables for commercial marketing application(s)
• Technical Review of supporting documents (CoA, declarations, SMF, MBR, SOPs)
• Evaluate change proposals for regulatory impact and provide regulatory guidance to enable global implementation
• Participate in regulatory intelligence activities as they pertain to global regulations and guidance, and provide regulatory advice to project teams
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
• Participate in initiatives aimed at improving internal departmental standards and systems

What are we looking for?

• Minimum of a Bachelor's degree in relevant field of study.
• 5+ years of relevant pharmaceutical industry experience and demonstrable track record of accomplishments preferably for  Reg Affairs, Manufacturing, QA/QC 
• Develop and maintain knowledge of FDA, HC, EMA and ICH regulatory requirements 
• Excellent presentation skills and ability to communicate effectively at multiple levels of the organization
• Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution.
• Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
• Able to understand and interpret data/information and its practical application.
• Able to problem solve and apply skills to determine risk exposure and communicate potential issues to management
• Agility to work remotely with remote supervision

Cybin Inc. is an Equal Opportunity Employer that is committed to inclusive, barrier-free recruitment and selection processes. In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, 2005, we are proud to provide employment accommodation during the recruitment process. Should you require an accommodation, please contact us as soon as possible and we will work with you to meet your accessibility needs. We welcome applications from all qualified candidates. We thank all those who apply. However, only those selected for an interview will be contacted.