Australia: Senior Regulatory Affairs Associate Cann Group Limited

Senior Regulatory Affairs Associate

Cann Group Limited
Mildura & Murray
Healthcare & Medical
Pharmaceuticals & Medical Devices
Full time
Posted 2d ago

About Cann Group Limited


Cann Group Limited is building a world-class business focused on breeding, cultivating, manufacturing and supplying medicinal cannabis for sale and use within Australia and for approved overseas export markets. Cann also owns Satipharm, a Europe-based business exclusively licensed to manufacture, develop and market the proprietary Gelpell delivery system for cannabinoids. Cann has established research and cultivation facilities in Melbourne and is developing a state-of-the-art cultivation and manufacturing facility near Mildura, Victoria. Cann Group has established a leading position in plant genetics, breeding, extraction, analysis and production techniques required to facilitate the supply of medicinal cannabis for a range of diseases and medical conditions. The Company is commercialising a range of imported and locally sourced and manufactured medicinal cannabis products.

Learn more at: www.canngrouplimited.com | www.satipharm.com

Position Summary


This role will support the legal and regulatory affairs function of the business, providing highly specialized regulatory services across the organisation, including managing regulatory compliance, preparation and submission of accurate regulatory documentation, performing research and preparing regulatory strategies, implementing process improvements and providing regulatory advice and support across the business as needed.

Key Responsibilities and Accountabilities


  • With the support of the Regulatory Affairs Manager, manage and lead the range of products supplied by Cann to ensure compliance with all internal and external regulatory requirements for Australia.
  • Manage on-going compliance requirements, such as licence renewals, registrations, variations, notifications, reports and submission to the regulatory authorities.
  • Develop regulatory strategies to support the Cann business.
  • Prepare, collate and compile documentation required for regulatory dossiers, drug master files, licence renewals and responses to regulatory authority questions for example.
  • Undertake research and preparation of advice in respect of local regulatory updates to the Act, Regulations, Guidance’s and Therapeutic Goods Orders and feedback impact to the business as required.
  • Review and assessment of proposed changes to product or facilities.
  • Organisation and maintenance of legal and regulatory registers and filing systems.
  • Manage workflow for the legal and regulatory function, including tracking progress and due dates of open matters, licensing and data entry.
  • Develop key relationships with various Cann departments as required to ensure regulatory services are integrated with operations.
  • Contributing to team discussions and providing innovative suggestions around process improvements and provide regulatory advice to Cann Group Limited to assist with good business decision making.
  • Prepare and maintain Standard Operating Procedures for regulatory associated activities, as applicable.
  • Build and maintain an effective working relationship with Regulatory Authorities to achieve business goals.

Person Specification


Qualifications / Licences

  • Tertiary Qualification in Life Sciences (i.e. chemistry, biology, microbiology, veterinary, pharmacy etc.).
  • Current Driver’s Licence (Victoria).
  • Police clearance

Experience

  • Educated to a degree level in pharmaceutical, medical or science related subjects.
  • Minimum 5 years pharmaceutical industry experience in regulatory affairs preferred.
  • Strong working knowledge of regulatory affairs and hands-on experience with regulatory planning, submission preparation and discussions with regulatory authorities.
  • Highly skills in prioritising work and meeting deadlines.
  • Strong ability to work with a high degree of independence and with sensitivity and confidentiality.
  • Exceptional proofreading skills; accurate with meticulous attention to detail.
  • Skilled in applying complex legislative, regulatory and policy requirements to a range of facts and circumstances and can take the next step to provide practical solutions in novel scenarios.
  • Computer literacy with MS Word and Excel. Proficiency with project planning and eCTD software would be advantageous

Skills

  • Maintain a calm demeanour when expectations change, or things don’t go as planned.
  • Strong ability to adjust frame of thinking and quickly change priorities.
  • Excellent attention to detail and completion to timelines.
  • Excellent organisational skills, ability to handle multiple tasks effectively.
  • Strong analytical and problem-solving skills.
  • Strong oral and written communication skills.
  • High degree of self-direction and initiative

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