Regulatory Affairs Associate

Regulatory Affairs Associate

Что мы делаем

At Kenvue, мы осознаем необычайную силу повседневной заботы. Основанный на более чем вековом наследии и уходящий корнями в науку, мы являемся домом культовых брендов, включая NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® и BAND-AID®, которые вы уже знаете и любите. Наука – наша страсть; забота – это наш талант.

Кто мы

Наша глобальная команда – это ~ 22 000 блестящих людей с культурой рабочего места, где каждый голос имеет значение, а каждый вклад ценится. Мы увлечены идеями, инновации и стремление поставлять нашим клиентам лучшие продукты. Обладая опытом и эмпатией, быть Kenvuer означает иметь возможность влиять на миллионы людей каждый день. Мы ставим людей на первое место, заботимся о настолько, завоевываем доверие наукой и смело решаем – и вас ждут блестящие возможности! Присоединяйтесь к нам, чтобы формировать наше будущее и ваше. Для получения дополнительной информации, нажмите here.

Role reports to:

Senior Regulatory Affairs Manager

Местонахождение:

Asia Pacific, Australia, New South Wales, Sydney

Место работы:

Гибрид

Что ты будешь делать

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

Если вы являетесь человеком с ограниченными возможностями, пожалуйста, ознакомьтесь с нашим страница помощи инвалидам для получения информации о том, как запросить приспособление.