Regulatory Affairs Associate

vor 1 Woche

Sydney, Österreich Tideri Jobbörse Vollzeit

Great opportunity to get your foot in the door with a market leading pharmaceutical company.
11th October, 2024 DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.
With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions that enhance the well-being of our customers.
Arrotex Pharmaceuticals is the largest and most diverse pharmaceutical company in Australia.
Our vision is to be the most trusted provider of affordable and quality healthcare products and services to deliver a better quality of life for Australians.
Our values of Pioneering, Accountability, Collaboration, and Tenacity are the PACT our team members make to be our best every day and work together to deliver this vision and create a great place to work.
About the role: We are in need of a Regulatory Affairs Associate with experience in complementary medicines to join our team.
This individual will work collaboratively with the Scientific Affairs team and stakeholders to deliver our regulatory strategies and compliance objectives.
Role & Responsibilities: Responsible for the review and preparation of quality regulatory submissions to ensure timely approval from the TGA and Medsafe within own portfolio.
Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance of products in own portfolio across the Australia and New Zealand markets.
Liaise with functional groups (Quality Assurance, Supply Chain, Pharmacovigilance/Medical Information and Marketing) to request and/or provide documents relevant to Change Control and product maintenance.
Accountable for assessing, coordinating and compiling deficiency responses in a timely manner.
Assisting in developing and maintaining Product Information, Consumer Medicine Information, labels, and other documentation as required.
Assisting in developing draft artwork and liaise as necessary with marketing to enable the production of labels, cartons and foils in line with relevant TGA guidelines.
Perform regulatory affairs activities associated with product launches (e.g.
provision of information required for PBS applications, ensuring registered details are current, etc.
).
Assisting in the coordination of regulatory affairs projects, as assigned.
Skills & Experience: Minimum of 1 year in Regulatory Affairs (pharmaceutical industry) or similar relevant experience ideally in the complementary medicines area.
Tertiary qualification in Pharmacy, Health, Science or a related discipline.
Business and organisational awareness related to the understanding of the business and/or regulatory agency's authority, structure and activities.
Understanding of both regulatory and scientific matters.
Ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
An awareness of the legislation governing the approval of products.
Knowledge and skills to conduct external liaison, negotiation, and/or collaboration with stakeholders.
Advanced written, verbal and listening communication skills – produces well thought-out, professional written correspondence free of grammatical and spelling errors; speaks with confidence, clarity and is easily understood; active listening to effectively receive, interpret and analyse information.
Strong technical writing skills, with the ability to write for a variety of audiences, gather and develop technical information to present in a clear and comprehensible format and design.
Excellent skills in Microsoft Office 365 including Word, Excel, Power Point, Outlook, Share Point, One Drive, Forms, etc.
Benefits & perks: At DBG Health, we offer more than just a job – we offer a dynamic and supportive work environment where you can make a real impact.
As part of our team, you'll have the opportunity to work alongside industry leaders, drive meaningful change, and grow both personally and professionally.
Competitive salary package and STIP program.
Exclusive discounts on our consumer health, wellness and beauty products - including MCo Beauty, E.
L.
F Cosmetics, Nude by Nature, Chemists Own and many more.
Free membership to 28 by Sam Wood - an online program designed to help Aussies get fit at home and live happier, healthier lives.
12 weeks paid parental leave.
We are a values-driven business fostering a supportive and friendly team culture.
Enjoy the ability to work autonomously, empowering you to drive your own success.
Opportunity to grow your career across all divisions within DBG Health - Arrotex Pharmaceuticals, Vida Corp Consumer Goods, Independent Pharmacies of Australia Group and Axe Health Services.
DBG Health is committed to fostering a workplace culture that is safe and accessible for all.
We are an equal-opportunity employer and encourage applications regardless of cultural background, gender identity, sexual orientation, disability or neurodiversity.
We strive to build a collaborative, inclusive workplace that is representative of the communities we work and live in.
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