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Regulatory Affairs Manager

Santé Cannabis

This is a Contract position in Westmount, QC posted November 30, 2020.

Position: REGULATORY AFFAIRS MANAGER Schedule: 9:00 AM TO 4:30 PM (OCCASIONAL WEEKENDS MAY BE REQUESTED) Location: MONTREAL (OCCASIONAL WORK FROM HOME FLEXIBILITY) The Regulatory Affairs Manager reports directly to the Director of Clinical Operations, and is responsible to ensure that clinical activities and all research services provided by Santé Cannabis are conducted according to all applicable regulations, and that all standard operation procedures are maintained in compliance with GCP/ICH guidelines, and to the Sponsor’s satisfaction.

ABOUT US Santé Cannabis is a medical clinic, research and training centre where: WE TRANSFORM MEDICINE by leading the way towards better science, better patient care and better medical cannabis.

WE INNOVATE AND ADVOCATE relentlessly to promote education and research that empower patients and caregivers.

WE’RE BUILDING A FUTURE where evidence-based medical cannabis treatments will be fully integrated into the healthcare system and free of stigma; improving the quality of life of patients and the diverse communities that support them.

If you are looking to make a difference, are highly motivated, enjoy challenges, and want to be heard, this the right job for you WHY SHOULD YOU APPLY?

– Being part of a dynamic, diverse and dedicated work environment
– Training budget set aside for your professional development
– Ability to grow within the company
– Flexible schedule and possibility to work from home
– Unlimited coffee in-office
– Help with balancing work-life demands
– Onsite wellness activities available to all employees
– Fun employee initiatives and dynamic employee appreciation rewards program
– Comprehensive benefits package including, health and dental coverage, RRSP company-matching program and 4 days paid time off JOB RESPONSIBILITIES
– Ensure compliance with the Canadian Regulations, Acts, and associated policies with the federal and provincial government, including but not limited to the Cannabis Act, the Controlled Drugs and Substances Act, the Food and Drug Act, and any other applicable regulatory frameworks as assigned;
– Ensure compliance with international regulations and associated policies where needed;
– Develop regulatory affairs practices improvement initiatives, development of tools, processes and training materials;
– Support department directors to update policies and procedures to maintain regulatory compliance as required;
– Support training of associated positions to ensure alignment of practices across the team through adoption and use of all process and technology tools;
– Ensure adequate resources (i.e.

headcount, experience, training) to sustain activities of regulatory affairs group;
– Oversee the compliance and maintenance of the Trial Master File(s) (TMF) including initiation, quality control, and coordination with other functional areas to ensure consistent procedures and inspection-readiness;
– Oversee and participate in the central ethics and sites submissions process for various protocols and on behalf of investigators or sponsors as assigned;
– Oversee and participate in the preparation and maintenance of Clinical Trial Applications (CTA, CTA-A, CTA-N) to Health Canada (Clinical and CMC);
– Prepare the regulatory submissions, and coordinate the responses to Health Canada, FDA and other regulatory bodies as required;
– Supervise a small team of 1-2 employees;
– Work with the Director of Clinical Operations to execute regulatory responsibilities on client contracts and to ensure efficient development of regulatory procedures and project assets;
– Support the role of Director of Clinical Operations and other departmental managers as assigned by performing regulatory review of documents, authorizing receipt or shipment of investigational products and by overseeing the activities associated with SAE management/pharmacovigilance and other compliance responsibilities;
– Monitors safety regulation compliance and project outcomes by completing regular, proactive scheduled and unscheduled self-inspection of processes, practices and documents to identify weaknesses or opportunities of improvement reporting to appropriate management;
– Oversees the maintenance of Quality system management of Standard Operating Procedures (SOPs/POLs) in accordance with regulatory requirements.

Communicates policies and procedures to appropriate team members and senior management and implements training as required;
– Assist with the management of regulatory inspections and regulatory processes such as product transfers, exports/imports, exemption applications, security clearances, security incidents, loss/thefts, adverse reactions, product destruction, and non-conformance’s as assigned;
– Support sponsor and client relationship as required by assigned project members and directors;
– Prepare and present regulatory project plans to clients, including domestic and international recommendations for target markets and according to client objectives;
– Produce yearly, quarterly, monthly and other related reports as required by the relevant regulations;
– Write, update, and implement Standard Operating Procedures, assist with document control, review of product labels and advertising, as assigned;
– Support Santé Cannabis Directors with specific projects as assigned.

SKILLS REQUIRED
– M.Sc.

in drug development, regulatory affairs, clinical development or in related life science discipline
– Minimum 3-5 years in pharmaceutical industry
– Strong knowledge of the Canadian regulations and the proven ability to interpret policies and guidelines
– Strong clinical development scientific knowledge
– Excellent communication skills
– Fully bilingual in French & English (written & spoken)
– Accountable, dedicated and able to work independently and in team settings
– Critical thinking
– Efficient and ability to learn new computer programs
– Adaptability in a changing environment
– Efficient with MAC computers If you are interested, please submit your CV and letter of motivation.

We thank all applicants for their interest, however, only candidates under consideration will be contacted.

At Santé Cannabis, diversity is part of our identity and we are proud to be an equal opportunity employer for all employees, regardless of race, colour, religion, gender, sexual orientation, national origin, genetics, age, disability, veteran status or any other discriminatory characteristic.