Little Green Pharma is a first mover and market leader in Australian-grown, cultivated and manufactured medicinal cannabis. We are a responsive organisation with a proven ability to quickly adapt, succeed and differentiate in a rapidly expanding global market. We are driven by a strong belief that everybody deserves good health and our goal is to provide targeted and natural therapeutic solutions that transform the lives of patients globally.
The opportunity
Located in Perth this is a full-time permanent opportunity for an exceptional person who is passionate about a career in Regulatory Affairs. The role will suit candidates who are looking to build on their existing experience in regulatory affairs or a related discipline. The Associate will work closely with an experienced Regulatory Affairs Manager based in Sydney and our General Counsel and Operations team based in Perth. The role will work across the business supporting the commercial, operations, marketing and quality teams.
The role
- Liaise with a broad range of regulators, such as the Office of Drug Control, Drug Control Section, WA State Health, TGA, and international jurisdictions for import and export
- Build productive and professional relationships with regulators to facilitate licensing and permitting
- Prepare and submit regulatory applications and notifications to ensure regulatory compliance and approvals
- Work with Regulatory Affairs Manager to prepare and submit regulatory applications such as dossier preparations and submissions, marketing authorisations, product registrations and variations and audits
- Review educational and marketing material to ensure regulatory and legal compliance
- Support pharmacovigilance system and requirements
- Maintain relevant regulatory systems and databases
Skills and Experience
- Tertiary qualification desirable in Pharmacy, Pharmacology, Biomedical science, relevant life science subject or a legal background
- Experience in the following areas will be highly regarded:
- regulatory affairs in a pharmaceutical company with domestic and international markets
- import and export experience
- Office of Drug Control experience
- Experience and capacity to interpret regulations and implement practical solutions
- Super-organised, diligent and achievement focused
- Ability to work well across the Company and to develop productive and collaborative relationships
- Good decision-making skills
- Ability to analytically solve problems
- Project and resource management skills
- Thorough and detailed
- Excellent writing skills
- Ability to prioritise time and manage multiple deadlines
Culture Fit
- Aligns with the values of Trust, Quality, Determination, Passion and Imagination
- A desire to do the best for the patient
- Strong work ethic
- Determined, dedicated, and driven to achieve
- Transparent and honest
- Enjoys working together to meet common goals
- Capacity to work autonomously to achieve important commercial outcomes
Please apply by hitting the Apply Button, uploading your resume and providing a cover letter which outlines your relevant education and experience.
Applications will be treated in the strictest confidence
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