Regulatory Affairs Associate

Regulatory Affairs Associate

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Senior Regulatory Affairs Manager

Ubicazione:

Asia Pacific, Australia, New South Wales, Sydney

Luogo di lavoro:

Ibrido

Cosa farai

Note that this is a 12 months contract

Assists the Regulatory Affairs Manager or Senior Regulatory Affairs Associate with the regulatory maintenance of a portfolio of products. This includes due diligence and regulatory related activities in line with the Australian and New Zealand authorities and government departments for registration of new products, ingredients, changes to marketed products, advertising approvals and consultations as required, across mainly Cosmetics/Beauty, Skin health and some Therapeutic Goods.

Key Responsibilities

• Critically analyse data packages and ingredients for regulatory compliance or new products for cosmetics and Therapeutic Goods as required and identify discrepancies in data presented and request additional data.
• Prepare and ensure timely and efficient applications for registration of new products and variations to marketed products for cosmetic, therapeutic goods and consumer good internal approvals.
• Assist in the development of labelling, and develop product information, consumer medicine information in accordance with relevant regulations and codes for cosmetics and medicines
• Prepare responses to deficiency letters and other requests for data from regulatory agencies.
• Assist in the preparation of rescheduling applications, as required.
• Develop and maintain strong relationships with government officials (TGA, Medsafe, NZ EPA and AICIS), and industry associations through attendance at meetings, conferences and seminars, as appropriate, to ensure compliance with the regulations, information sharing and influence is optimized in relation to individual product portfolios.
• Assist in identifying, reviewing and disseminating information to relevant company personnel to ensure awareness and compliance with new regulations/codes and their subsequent amendments.
• Liaise with Regulatory Affairs Manager to provide ongoing status updates of current activities and to determine and manage workload. Attend Project team meetings with Project Team to ensure timely and accurate communication on projects maintained.
• Maintain an up to date knowledge of the relevant legislation in Australia and New Zealand relating to cosmetics, therapeutic goods and consumer goods as required.
• Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.
• Maintain regular documentation and databases.
• Review and provide Regulatory Affairs approval of advertising and promotional materials ensuring accuracy and compliance with codes of conduct.

What We Are Looking For

Required Qualifications

• Degree in Pharmacy, life science or similar discipline
• 1- 2+  years related experience
• Has background on either Costmetics/Beauty, Skin health, and Essential health
• Established Health Authority and Industry Association connections
• Ability to analyse, interpret and communicate technical information
• High level of computer literacy

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