Manager – Regulatory Affairs

Job Description

• Update company’s Product Information (PI) and Consumer Medicine Information (CMI) documents in line with the innovator PIs and CMIs as per the TGA required timelines. 
• Report medicines shortages to the TGA in accordance with legislated timelines and internal procedures.
• Support compilation of new generic submissions to TGA or Medsafe
• Respond to questions from the TGA or Medsafe and complete regulatory activities, including labelling updates, to comply with local legislations to support continued product supply.
• Compile and submit post approval variations and GMP clearances for prescription and Over-the-Counter (OTC) medicines. 
• Maintain internal/external databases and work trackers to ensure company’s information contained within is accurate and up to date.
• Ensure invoices are processed and shared with Lupin’s Finance team in accordance with internal procedures. 
• Assist with the preparation of Australian Specific Risk Management Plans (RMPs).
• Publish dossiers/variations in NeeS and/or e-CTD format.
• Liaise with external consultants to complete outsourced regulatory activities to meet business goals.
• Review change controls from manufacturers and provide regulatory assessment according to the current TGA guidelines and company’s internal processes.
• Stay up to date with applicable legislations, regulations and guidelines relevant to prescription and OTC medicines supplied by the company. Share information with the rest of the regulatory team and key stakeholders.
• Provide regulatory guidance and advice to third-party manufacturers, quality assurance, supply chain, sales and marketing, business partners or ANZ commercial teams.
• Assist with the preparation of reports requested by the TGA including input into risk assessments to any identified GMP non-compliance signals to justify continued supply of products in Australia and/or New Zealand.  
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Work Experience

10 to 15 years in Australia and New Zeland Regulatory Affairs. 

Education

Competencies