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Regulatory Affairs Associate

職務分類:
掲載日:
終了日:
ID:
2507039356W

この仕事を共有する:

Kenvueは現在、以下求人を募集しております。

Regulatory Affairs Associate

私たちがしていること

私たちKenvueは、日々のケアが持つ驚くべき力を信じています。100年以上の伝統と科学に根ざし、Neutrogena®, Aveeno®, Tylenol®, Listerine®, Johnson’s® and BAND-AID®など、皆様が既にご存じでご愛用いただいているアイコニックなブランドを提供しています。科学は私たちの情熱であり、ケアは私たちの才能です。 

Who We Are

私たちのグローバルチームは、インサイトとイノベーションに情熱を注ぎ、最高の製品をお客様にお届けすることに全力を注ぐ、多様で優秀な22,000人以上の社員で構成されています。専門知識と共感力を備えたKenvuerであることは、毎日何百万人もの人々の生活に影響を与える力を持つことを意味します。私たちは、人を第一に考え、全身全霊をもってケアし、サイエンスで信頼を獲得し、勇気をもって解決します。私たちとあなた自身の未来を、共に切り開いていきましょう。 

Role reports to:

Senior Regulatory Affairs Manager

場所:

Asia Pacific, Australia, New South Wales, Sydney

勤務地:

ハイブリッド

あなたがすること

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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