Regulatory Affairs Manager Avicanna Toronto, ON

Avicanna is a diversified and vertically integrated Canadian biopharmaceutical company focused on the research, development, and commercialization of plant-derived cannabinoid-based products for the global consumer, medical, and pharmaceutical market segments. Avicanna is a company that is focused on quality control and excellence with many cannabinoid product offerings in Canada, USA, Colombia, and other markets. Avicanna has its cultivation and extraction facility based out of Santa Marta, Colombia. Avicanna’s research and development team is based out of Toronto, Canada with its laboratories located in the Johnson & Johnson Innovation Centre (JLABS) in the MaRS Discovery District. Avicanna is also proud to be continuously developing clinical development programs through world-class research Hospitals and Universities.

At Avicanna, we know that our greatest asset is our people, and we work every day to ensure that we provide a challenging, exciting, and rewarding environment to be a part of. Our team is dedicated, innovative, and driven to improve the quality of life by combining a passion for transforming lives with research excellence. If you are excited by the opportunity to change lives and believe in the impact that natural cannabinoid solutions can have, consider a role with our team.

We are currently seeking a Regulatory Affairs Manager for the development and commercialization of innovative cannabinoid-based medical, cosmetic and nutraceutical products that will transform patient and consumer’s quality of life. The regulations in the medical cannabis industry are exciting and rapidly changing, its imperative that we are informed, and our products meet or exceed the standards. This role reports to the president and work with SVP of R&D, VP of medical, EVP of marketing all in Canada and senior team in South America as well.

ROLES AND RESPONSIBILITIES

  • Responsible for the regulatory oversight of all Avicanna’s clinical and commercial initiatives: cosmetics, nutraceuticals, and pharmaceuticals including liquid, semi-solid and solid forms for oral and topical applications (e.g. creams, gels, powder, and liquids) in several geographic regions including Canada, the US, the EU and LATAM
  • Oversee product development, testing, manufacturing, marketing, and distribution processes to ensure each process is compliant with the relevant regulatory statutes implemented by various regulatory agencies.
  • Prepare routine regulatory submissions for investigational and marketed products (e.g., Investigator brochures, Clinical Trial Applications, New Drug Submissions (NDS), Supplemental NDS, post-Notice of Compliance changes, Investigational New Drug (IND) applications, Orphan drug applications etc.) in line with Canadian, US, EU, LATAM and ICH requirements and company policies and procedures.
  • Provide support for the scientific, medical, and marketing teams on regulatory issues important to drug development, assigned products, disease/therapeutic areas and commercialization.
  • Assist in all quality and regulatory procedures (ICH guidelines, GLP/GMP), maintenance of documents, implementation, and training.
  • Adhere to all GMP, ISO, and international regulatory requirements for reviewing protocols, validation, and qualification reports, finished product specifications, and summaries of experimental data for internal and external reporting requirements.
  • Draft, coordinate and review relevant documents including packaging, labels, websites and other marketing content to ensure compliance.
  • Participate in regulatory meetings with Health Canada, INVIMA, FDA and other regulatory bodies and assist in preparing responses to requests for general information.
  • Oversee record keeping and documentation compliance.
  • Coordinate with global regulatory team members and maintain up to date understanding of regulatory guidelines (Health Canada, ICH, FDA, etc.)
  • Other duties as assigned.

EDUCATION AND EXPERIENCE:

  • At minimum, a master’s degree in a related field (i.e., pharmaceutical) with accreditation in relevant associations and regulatory discipline required.
  • 5+ years experience in regulatory and quality related position in the cannabis sector, pharmaceutical sector, or other regulated product sectors
  • Experience in writing regulatory applications e.g., Investigator brochures, Clinical Trial Applications, New Drug Submissions (NDS), Supplemental NDS, post-Notice of Compliance changes, Investigational New Drug (IND) applications, Orphan drug applications etc.
  • Bilingual in Spanish and English is preferred
  • Excellent verbal and written communication skills
  • Able to collect, summarize, and interpret complex regulatory statutes and information from a variety of sources.
  • Able to demonstrate strong leadership skills and collaborate productively and efficiently with multiple internal and external stakeholders.
  • Strong knowledge of Cannabis Act & Regulations
  • Ability to work independently and efficiently with little supervision.

Job Type: Full-time

Salary: $50,016.00-$83,655.00 per year

Benefits:

  • Casual dress
  • Dental care
  • Extended health care
  • On-site gym
  • Paid time off
  • Vision care

Schedule:

  • 8 hour shift
  • Monday to Friday
  • Overtime

Experience:

  • Regulatory: 3 years (Required)

Education:

  • Bachelor’s Degree (Required)

COVID-19 precaution(s):

  • Remote interview process
  • Personal protective equipment provided or required
  • Social distancing guidelines in place
  • Virtual meetings
  • Sanitizing, disinfecting, or cleaning procedures in place

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