Regulatory and Quality Affairs Manager

• Set-up and maintain local regulatory systems and processes, including registration database.
• Review and audit CTD dossiers made available from global organisation. and provide input into the registration strategy to build the portfolio. In conjunction with the General Manager, prepare a submission plan for new molecules and implement according to agreed timelines.

Client Details

They are a major supplier of generic injectable products in the Australian and New Zealand markets. They have grown significantly over the past five years and look forward to further growth with a broad and growing portfolio of parental medicines.

Description

They are a small organisation, and this role will have responsibility within the quality and regulatory function in Australia and for New Zealand. A flexible, can-do attitude is paramount, as is the ability to work proactively within a team environment but also autonomously with minimal guidance. Reporting directly to the General Manager, the successful candidate will have the following responsibilities:

• Set-up and maintain local regulatory systems and processes, including registration database.
• Review and audit CTD dossiers made available from global organisation. and provide input into the registration strategy to build the portfolio. In conjunction with the General Manager, prepare a submission plan for new molecules and implement according to agreed timelines.
• Drive local regulatory strategies for upcoming registrations.
• Ensure maximum harmonisation of local and global dossiers.
• Maintain existing registrations including periodic updates and variations as required in Australia and New Zealand (e.g. site transfers, alternate API manufacturers, changes to specifications, methods, shelf life etc).
• Maintain labelling (Carton, label, PI/DS and CMI).
• Liaise with Global Regulatory.
• Apply for new or renew GMP clearances.
• Provide Regulatory feedback to interdepartmental customers (commercial, central quality).
• Manage Regulatory and Pharmacovigilance reporting to above country.
• Review and communicate Regulatory Intelligence for Australia and New Zealand.
• Create/maintain departmental procedures, processes and databases.
• Obtained/maintain company Poisons Licence.
• Creation of required Quality Agreements.
• Audit third party providers as required.
• Complete the internal quality check for product released to Australia (specifications, temperature loggers, artwork etc.).
• Manage Customer Complaints and Medical Information queries; receipt and logging, liaise with manufacturer, communication of outcomes to customer.

Profile

The ideal candidate will have five or more years' experience compiling, submitting and following registrations through to approval. The ability to interact directly with the TGA and Medsafe is essential to the role.

Experience with injectable products will be viewed favourably, as will previously experience in a Quality function. Excellent written and verbal communication skills are a must and experience working in a multi-national, multi-cultural environment would be an advantage.

The candidate will understand the importance of the quality and regulatory roles to business success and see themselves as a key part of the team driving the growth of the business. They will look for opportunities to make a difference to the business through their role.

Job Offer

Be a part of a fast growing pharmaceutical company with a huge global presence

To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Shruti Patro on +61 2 8221 8144.