Australia: Senior Regulatory Affairs Associate Cann Group Limited Melbourne VIC

Senior Regulatory Affairs Associate

Cann Group Limited
Melbourne VIC
Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Posted 2d ago

About Cann Group Limited


Cann  Group Limited is enhancing patients’ lives by developing, producing, and supplying innovative cannabis medicines. The Company has built world-class research, cultivation and GMP manufacturing facilities in Melbourne, and a state-of-the-art large-scale cultivation and GMP manufacturing facility near Mildura, Victoria. Cann Group supplies a range of dried flower and oil products, as well as active pharmaceutical ingredients and extracts, to customers in Australia and around the world. Cann Group also owns Satipharm and its patent-protected capsule technology.
Learn more at: www.canngrouplimited.com | www.satipharm.com 

 

  • Join a progressive Australian leader in Medicinal Cannabis.
  • Enjoy competitive salary package and employment benefits like novated leasing, birthday and study leave, discounted health insurance etc.
  • Full time role with growth opportunity in a supportive and inclusive environment. 

 

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 ongoing compliance requirements, such as licence renewals, registrations, variations, notifications, reports and submissions 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 products 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.
  • Support the planning and resourcing of legal and regulatory compliance activities to ensure delivery to agreed time frames and cost.
  • Assist in the development and implementation of a system of recording, measuring and presenting compliance associated activities based on Key Performance Indicators.
  • Support improvements to reduce the cost of the operation of the Legal and Regulatory Affairs department and its stakeholders within the Company.
  • Perform all duties in a safe and compliant manner ensuring all procedures and processes implemented have no adverse impact on the safety of products or other individuals.
  • Escalate all safety concerns in a timely manner.
  • Keep up to date with developments in the appropriate legislation, regulations, guidelines & best practice as they relate to the local and international medicinal cannabis industry.
  • Build and maintain strong working relationships with key stakeholders including Cann management and third-party contractors.
  • Contribute to team success by working collaboratively across the business; assisting team members when needed; sharing ideas, knowledge and experience; and seeking to learn from team members.
  • Actively contribute to Cann’s risk-aware culture and performance through participating in operational risk training and adhering to relevant compliance and regulatory obligations.

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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