[Test of Change]

Menarini is going through an exciting period of growth and as a result we are seeking to employ a Senior Regulatory Affairs Associate to ensure product registration and maintenance of all regulatory activities for Menarini Australia and New Zealand in

compliance with regulations, Licensor Agreements and SOPs to maintain product viability in the marketplace throughout its

lifecycle. 

Role accountabilities:

• provide a high quality of Regulatory Affairs services to Menarini Australia and New Zealand, ensuring that all regulatory activities are compliant with local health authority regulations and Menarini Corporate and Licensor requirements
• ensure pre-submission planning forms and applications are submitted by the agreed timelines and that all applications are accepted without major deficiencies identified
• ensure all dossiers prepared for submission have been self-reviewed for scientific accuracy and compliance with the relevant global reference documents
• keep track of and complete post-approval commitments according to the agreed regulatory timelines
• keep all relevant stakeholders updated on the progress of each registration application

Responsibilities include (but not limited to):

• New Product Registrations and Major Applications
• Take complete responsibility for assigned new product registrations and major applications and ensure completion in the best possible time.

Tasks include:

• undertake full gaps analyses and advise on changes needed
• develop a project plan for the pre-submission, review and submission, taking into consideration internal
• expectations and advising stakeholders accordingly
• organise, prepare and submit briefing packages in concordance with Menarini Regional and Corporate Regulatory Affairs
• active participation in TGA and Medsafe pre-submission meetings
• take a leading and active role in cross-functional project teams
• Maintenance of Products
• effectively maintain current registrations to ensure products remain compliant with all relevant regulations and
• Corporate/ Licensor requirements
• upon request from Regional/ Corporate/ Licensor Regulatory functions, provide regulatory advice for assessment requests and planned change controls
• Organise, prepare and submit all required application types in Australia (including Category 1) and New Zealand with minimal oversight
• plan and undertake any required Health Authority commitments for products
• advise on GMP clearance requirements, and submit GMP clearance application for all assigned sites
• Product Information/ Data Sheet/ Consumer Medicine Information/ minimum Product Information
• prepare and submit PIs/DSs to HA for approval, in accordance with Menarini procedures and in compliance with
• Health Authority templates and timelines
• maintain PIs/DS and CMIs for products, ensuring the correct distribution and use of approved versions
• for consumer products, maintain consumer leaflets
• liaise with medical and marketing colleagues to prepare the minimum product information for promoted products
• PSUR, RMP and ASA
• review, update and submit the PSUR, RMP and ASA for required products in a timely manner, in compliance with
• registration conditions and applicable procedures
• communicate appropriate information to relevant internal stakeholders related to ongoing pharmacovigilance
• obligations
• Cosmetic Ingredient Importation
• prepare and submit applications for the importation of cosmetic ingredients in Australia and New Zealand
• Company Licences
• maintain and implement relevant importation, exportation and state licenses
• Quality and Supply
• advise quality and supply functions with implementation timelines for approved product changes
• assist quality function with registration detail requests and deviation/CAPA close-out
• Relationships Within and Outside the Company
• develop and maintain good working relationships with other cross-functional departments both locally and with the Regional and Corporate Head Office and locally licenced partners
• develop and maintain productive and beneficial relationships with health authority and industry bodies
• provide regulatory advice to internal stakeholders as necessary
• assist colleagues within the Medical, Pharmacovigilance and Quality Assurance department with product detail requests
• represent Regulatory Affairs at any required in-office, domestic or international meetings/conferences
• effectively communicate changes in regulations and guidelines to relevant stakeholders
• Required Requisites:

Experience and Qualifications:

• Tertiary qualification in Pharmacy, Life Science or related field
• minimum of 5 years’ experience in a Regulatory Affairs role in the pharmaceutical or biotechnology industry
• within the ethical vertical
• demonstrated experience in planning, preparation and negotiation of major submissions for new
• chemical and/or biological entities
• end-to-end experience in all application types (including Category 1) highly desirable
• experience in OTC, complementary, device and cosmetic areas highly desirable
• demonstrated ability to initiate and manage projects and actively engage in cross-functional meetings
• demonstrated understanding of relevant regulations and guidelines and ability to provide guidance to
• Menarini staff to ensure compliance with these.
• experience in planning and co-ordinating multiple complex projects simultaneously
• a clear understanding of highly technical scientific information
• strong computer literacy and command of Microsoft Office Suite, with ability to operate multiple information
• databases.

Skills and attributes

• Updated skills