Head of Regulatory Affairs and Compliance

November 21, 2017

Head of Regulatory Affairs and Compliance

The Cronos Group is a geographically diversified cannabis group that operates within Health Canada’s Access to Cannabis for Medical Purposes Regulations and distributes globally. We aspire to set best practices by building industry leading companies that transform the perception of cannabis and responsibly elevate the consumer experience. We are comprised of passionate, daring people, driven by quality and integrity.

We are currently recruiting for a Head of Regulatory Affairs and Compliance – Come join our dynamic team!

This position is based out of Stayner, ON.

Position Overview:

The candidates will be responsible for managing and leading Regulatory Affairs and Compliance to ensure compliance with the evolving regulations related to the cannabis industry.

RESPONSIBILITIES:

  • Plan, coordinate, compile and file licensing applications and license amendment applications.
  • Plan, coordinate, compile and file post approval submissions for Health Canada.
  • Review Change Controls and determine filling requirements.
  • Manage Corrective Action Plans and deliverables.
  • Participate in regulatory compliance inspections.
  • Emphasize and enforce regulatory compliance through all business units.
  • Liaise with Health Canada on all aspects of licensing and compliance, follow up for review status and project updates.
  • Work on more complex projects which involve identifying and resolving issues in a timely manner.
  • Review and approve, improve current procedures as they relate to the regulation including compliance with record keeping, product development, various product labeling components and marketing materials.
  • Assist in preparation and compilation of Health Canada pre-approval and GMP inspections.
  • Maintain current awareness of regulatory guidelines (Health Canada (ACMPR/CDS/PMRA), FDA, ICH, European Medicines Agency – EMeA, Therapeutic Goods Administration – TGA Australia, etc.).
  • Communicate new regulation and regulatory changes that impact the business.
  • Assist in understanding regulatory requirements and/or restrictions pertaining to new products, new processes, and new jurisdictions.

 

QUALIFICATIONS:

  • Minimum B.Sc. in a Chemistry, Pharmacy or related discipline combined with at least five (5) to seven (7) years of hands-on Regulatory Affairs experience of filing and managing Canadian submissions, including electronic submissions in eCTD formats.
  • Knowledge of the use of eCTD software.
  • Knowledge of GMP and GAP requirements and QA/QC procedures.
  • Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems).
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to plan, coordinate and work effectively in a team-oriented environment.
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.
  • Multi-tasking various tasks and adhering to strict timelines.
  • Flexibility and the ability to thrive in a fast-paced environment.

 

We will provide reasonable accommodation for qualified individuals with disabilities in the job application process.

We thank all applicants for their interest, however, only those selected for an interview will be contacted

To apply, please email cover letter and resume to: careers@thecronosgroup.com

 

76 Stafford Street, Suite 302

Toronto, Ontario M6J 2S1

Info@TheCronosGroup.com
Careers@TheCronosGroup.com

(416) 504-0004