Regulatory Affairs Associate

我們做什麼

在 Kenvue，我們意識到日常護理的非凡力量。我們以一個多世紀的傳統為基礎，植根於科學，是標誌性品牌的品牌 - 包括您已經熟悉和喜愛的 NEUTRGENA®、AVEENO、TYLENOL®®、LISTERINE®、JOHNSON'S® 和 BAND-AID®。科學是我們的熱情所在;關心就是我們的才能。

我們是誰

我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成，他們的職場文化中，每個聲音都很重要，每一個貢獻都受到讚賞。 我們熱衷於洞察， 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心，成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本，熱切關懷，以科學贏得信任，以勇氣解決——有絕佳的機會等著您！加入我們，塑造我們和您的未來。有關更多資訊，請按兩下 here.

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你會做什麼

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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