Regulatory Affairs Associate

Regulatory Affairs Associate

Wat we doen

Bij Kenvue realiseren we de buitengewone kracht van dagelijkse verzorging. Gebouwd op meer dan een eeuw erfgoed en geworteld in de wetenschap, zijn we het huis van iconische merken - waaronder NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON'S® en BAND-AID® die je al kent en waar je van houdt. Wetenschap is onze passie; Zorg is ons talent.

Wie we zijn

Ons wereldwijde team bestaat uit ~ 22.000 briljante mensen met een werkcultuur waar elke stem telt en elke bijdrage wordt gewaardeerd. We zijn gepassioneerd door inzichten, innovatie en toegewijd aan het leveren van de beste producten aan onze klanten. Met expertise en empathie betekent een Kenvuer zijn dat je elke dag de kracht hebt om miljoenen mensen te beïnvloeden. We stellen mensen op de eerste plaats, geven er veel om, verdienen vertrouwen met de wetenschap en lossen op met moed - en hebben schitterende kansen voor je klaarliggen! Geef samen met ons vorm aan onze toekomst - en die van jou. Klik voor meer informatie op here.

Rol rapporteert aan:

Senior Regulatory Affairs Manager

Locatie:

Asia Pacific, Australia, New South Wales, Sydney

Werklocatie:

Hybride

Wat je gaat doen

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

Als u een persoon met een handicap bent, kijk dan op onze pagina Hulp bij handicap voor informatie over het aanvragen van een accommodatie.