• Provide strategic direction to drive expansion of product portfolios and NPD/EPD initiatives in Australia, New Zealand, CBEC and International markets• Provide compliance advice on statutory and industry requirements related to the regulation of medicines and foods across various markets• Provide up to date, pragmatic and commercially focused advice and guidance regarding how regulatory challenges may affect sales, marketing, quality and operations• Develop regulatory risk… Show more • Provide strategic direction to drive expansion of product portfolios and NPD/EPD initiatives in Australia, New Zealand, CBEC and International markets• Provide compliance advice on statutory and industry requirements related to the regulation of medicines and foods across various markets• Provide up to date, pragmatic and commercially focused advice and guidance regarding how regulatory challenges may affect sales, marketing, quality and operations• Develop regulatory risk management processes to identify risk and recommend mitigation• Provide input into government consultations impacting the business• Lead and collaborate with cross-functional teams to deliver continuous improvement initiatives with focus on compliance and efficiency• Partner with external stakeholders to ensure seamless collaboration for technical transfers and change management activities• Analyse KPI metrics to celebrate successes and focus on areas of opportunity• Develop regulatory work flow processes to ensure due diligence and sponsor obligations are maintained• Lead an effective and responsive Pharmacovigilance and Regulatory team to deliver high quality performance in a fast-paced environment• Develop and inspire a talented team through career development and coaching Show less

•Identify and implement key strategic regulatory objectives in line with business priorities•Assess regulatory requirements and risks for new product innovations, and recommended pathways for successful registrations in Australia, New Zealand and overseas markets in Asia•Lead regulatory process reviews to optimize efficiencies and ensure compliance for; product dossiers, labelling and advertising reviews, claims evidence and product safety reviews, product specification and stability… Show more •Identify and implement key strategic regulatory objectives in line with business priorities•Assess regulatory requirements and risks for new product innovations, and recommended pathways for successful registrations in Australia, New Zealand and overseas markets in Asia•Lead regulatory process reviews to optimize efficiencies and ensure compliance for; product dossiers, labelling and advertising reviews, claims evidence and product safety reviews, product specification and stability reviews, lifecycle management, and change management•Provide education to cross functional teams on regulatory requirements across different products categories e.g. food, complementary medicines, and registered medicines•Ensure product registrations are compliant with marketing authorizations in all registered markets•Review Health authority consultations and provide input to responses on behalf of the organization•Liaise with Health authorities such as TGA, Medsafe and overseas Health authorities, external suppliers and contract manufacturers •Provide team leadership and guidance to ensure a cohesive and effective team where objectives are clear and executed according to agreed timelines•Manage team members by providing on-going coaching and feedback, and provide opportunities for development in current and future roles Show less

Responsibilites detailed under Blackmores (company transition from Nov 2019)

• Write and submit OTC and RCM dossiers for new product registrations in eCTD• Lead and project manage regulatory projects to support new product introductions• Provide regulatory guidance to internal and external customers• Critically review information for submissions with cross-functional areas• Submit product variations as part of life-cycle management• TGA pre-clearance applications• List and maintain products on the ARTG on TGA Business Services• Review product… Show more • Write and submit OTC and RCM dossiers for new product registrations in eCTD• Lead and project manage regulatory projects to support new product introductions• Provide regulatory guidance to internal and external customers• Critically review information for submissions with cross-functional areas• Submit product variations as part of life-cycle management• TGA pre-clearance applications• List and maintain products on the ARTG on TGA Business Services• Review product labelling for compliance with TGO69/92 and RASML• Schedule and prepare Product Quality Reviews• Write SOPs and WIs for company regulatory procedures• Train and mentor team members in regulatory activities Show less

• Write and submit OTC and RCM dossiers for new product registrations in eCTD• Prepare and submit responses to TGA Section 31 requests for product registrations• Provide evidence to support related post market surveillance activities for listed medicines• Evaluate raw materials for regulatory compliance according permissible ingredients and SUSMP• Apply for and maintain company licenses and permits• Co-ordinate and apply for Export certificates with Department of… Show more • Write and submit OTC and RCM dossiers for new product registrations in eCTD• Prepare and submit responses to TGA Section 31 requests for product registrations• Provide evidence to support related post market surveillance activities for listed medicines• Evaluate raw materials for regulatory compliance according permissible ingredients and SUSMP• Apply for and maintain company licenses and permits• Co-ordinate and apply for Export certificates with Department of Agriculture• Prepare regulatory documents to support; Halal certification and allergen declarations• Annual ACE declarations for domestic product registrations • Assist clients to compile regional regulatory dossiers. Countries include: New Zealand, UAE and Asia Pacific countries, Malaysia, Thailand, Vietnam, Singapore, Philippines and Hong Kong Show less

•Manage Quality systems across VIC and NSW sites to maintain ISO9001 accreditation•Maintain company procedures to ensure compliance to Quality standards and GMP•Conduct internal audits and supplier quality audits•Manage external customer audits and manage responses and close-out activities•Conduct investigations and prepare non-conformance reports to identify root causes and CAPA actions as a result of internal audit findings and customer complaints•Manage Change control… Show more •Manage Quality systems across VIC and NSW sites to maintain ISO9001 accreditation•Maintain company procedures to ensure compliance to Quality standards and GMP•Conduct internal audits and supplier quality audits•Manage external customer audits and manage responses and close-out activities•Conduct investigations and prepare non-conformance reports to identify root causes and CAPA actions as a result of internal audit findings and customer complaints•Manage Change control system•Prepare and conduct monthly quality management reviews with top Management•Organise and conduct training programs•Approve quality records for environmental monitoring of the Cleanroom Show less

Customer Complaints Associate Key Responsibilities: •Perform internal investigations and CAPA follow up for customer complaints•Perform batch document reviews, retain sample checks and counterfeit comparisons•Prepare trend analysis and monthly reports for products and defects identifiedChange Control Associate Key Responsibilities: •Manage all site change control activities•Support Regulatory audits to ensure compliance with TGA, GMP guidelines… Show more Customer Complaints Associate Key Responsibilities: •Perform internal investigations and CAPA follow up for customer complaints•Perform batch document reviews, retain sample checks and counterfeit comparisons•Prepare trend analysis and monthly reports for products and defects identifiedChange Control Associate Key Responsibilities: •Manage all site change control activities•Support Regulatory audits to ensure compliance with TGA, GMP guidelines and company policies•Work with cross-functional groups and management to resolve any change control issues•Compile metrics and trend reports for management review Show less

•Manage Microbiology team and deliver micro results within lead times•Prepare SOP’s to ensure processes are documented and followed•Participate in audits (TGA, Corporate & Customer), and closeout of audit commitments•Investigate and prepare reports using TrackWise, CAPA and LIMS systems•Train and conduct performance reviews for staff•Review and trend Environmental monitoring results•Participate in OH&S, QC, Micro and Leadership meetings to communicate key… Show more •Manage Microbiology team and deliver micro results within lead times•Prepare SOP’s to ensure processes are documented and followed•Participate in audits (TGA, Corporate & Customer), and closeout of audit commitments•Investigate and prepare reports using TrackWise, CAPA and LIMS systems•Train and conduct performance reviews for staff•Review and trend Environmental monitoring results•Participate in OH&S, QC, Micro and Leadership meetings to communicate key issues•Participate in Asia/Pac group for cross country collaboration•Use of GLP and GMP in an FDA and TGA accredited site•TAMC and selective testing, Microbial Identifications, Antibiotic Assays Show less