♦ Professional Growth Opportunity
♦ ASX Listed Pharmaceutical Company
♦ Flexible Working Environment
The Company is an Australian-based ASX listed pharmaceutical company that is developing high quality and clinically validated medicines. The Company is bringing together leading expertise across all aspects of the value chain to develop new medications for the treatment of neuropathic and chronic pain. This expertise includes extensive international & local collaborations and partnerships with industry experts, leading market participants, universities and clinicians.
Your remit is to work with management and the development team to create and deploy a compliant quality system for major target markets initially focused on Australia. You will provide leadership and oversight of the quality system and ensure compliance with all relevant regulatory environments to allow the commercialisation of the products.
♦ Development and implementation of Quality Management Systems including all documentation creation and control.
♦ Manage compliance with the TGA and ensure the company complies with the requirements of relevant legislation.
♦ Maintain knowledge and oversight of the relevant national and international standards: including TGA, EMA, ICH, PICS for the purposes of compliance to allow commercialisation of the products.
♦ Assisting the regulatory function in the preparation of dossiers to meet compliance and commercialisation requirements.
♦ Assisting the regulatory function in liaison with Regulators to obtain strategically-identified approvals.
♦ Accountability for ensuring that the quality systems are maintained, and readiness for audits.
♦ Development and implementation of a system to ensure all external communications and marketing material is compliant with relevant regulations and label claims.
♦ Providing advice for establishment of a quality system in other jurisdictions.
♦ Relationship management & travel across Australia to meet with stakeholders internally and externally at regular intervals.
♦ 3-5 years’ experience in a finished dose form pharmaceutical Quality Management role at Senior Associate or Manager level.
♦ Created quality systems modules as a whole, alone or under supervision.
♦ High level literacy skills.
♦ Able to think logically and in a systems-oriented manner.
♦ Highly organized with the ability to multi-task and work both independently and collaboratively.
♦ Science or Engineering tertiary qualification in an appropriate field – Pharmaceuticals, Biotechnology, Engineering, Chemistry, Pharmacy.
You will work within a high performing team, enjoy autonomy and a flexible environment, with the ability to work from home. As a valued member of this team you will have the opportunity to demonstrate your talent and shape this growing business.
This role is envisaged to be based in Melbourne. Other states may be considered for the right candidate.
Regular domestic travel will be required.
If you are interested in joining our client in this exciting new challenge, please call Marilyn from Marilyn Careers on 0437 332 272 for a confidential discussion and email your resume & cover letter to firstname.lastname@example.org