Regulatory Affairs Associate

This is a great opportunity to get your foot in the door with a market leading pharmaceutical company 29th August, 2024 About DBG Health & Arrotex Pharmaceuticals: DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.
With a team of over 1,000 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: Our Regulatory Affairs team is growing, and we are now in need of a Junior Regulatory Affairs Associate.
This individual will work collaboratively with the Scientific Affairs team and stakeholders to deliver our regulatory strategies and compliance objectives.
The Regulatory Affairs Associate interacts with relevant internal departments as well as external partners (Affiliates/Joint Venture Partners and other International/Local Customers) and regulatory authorities (Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand) to ensure that product applications are submitted, approved and launched promptly.
Role & Responsibilities: Assist in developing and maintaining product information, consumer medicine information, labels, and other documentation as required within the timelines specified by the Regulatory Agency.
Assist in the maintenance of GMP clearance in line with TGA requirements Assisting in developing draft artwork and liaising as necessary with Marketing to enable the production of labels, cartons, and foils Assisting in proofreading Labels, Product Information documents, Consumer Medicine Information (or equivalent) documents and other documentation Keeping documentation such as Product Information, Consumer Medicine Information, and labelling (or equivalent) updated on our database and external databases to ensure the most recent document is available 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.
Perform additional duties as assigned by the Regulatory Affairs Manager.
Assists the business by reporting the status of regulatory affairs activities in various project meetings or upon request from other departments.
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 29th August, 2024 About DBG Health & Arrotex Pharmaceuticals: DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.
With a team of over 1,000 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: Our Regulatory Affairs team is growing, and we are now in need of a Junior Regulatory Affairs Associate.
This individual will work collaboratively with the Scientific Affairs team and stakeholders to deliver our regulatory strategies and compliance objectives.
The Regulatory Affairs Associate interacts with relevant internal departments as well as external partners (Affiliates/Joint Venture Partners and other International/Local Customers) and regulatory authorities (Therapeutic Goods Administration (TGA) in Australia and Medsafe in New Zealand) to ensure that product applications are submitted, approved and launched promptly.
Role & Responsibilities: Assist in developing and maintaining product information, consumer medicine information, labels, and other documentation as required within the timelines specified by the Regulatory Agency.
Assist in the maintenance of GMP clearance in line with TGA requirements Assisting in developing draft artwork and liaising as necessary with Marketing to enable the production of labels, cartons, and foils Assisting in proofreading Labels, Product Information documents, Consumer Medicine Information (or equivalent) documents and other documentation Keeping documentation such as Product Information, Consumer Medicine Information, and labelling (or equivalent) updated on our database and external databases to ensure the most recent document is available 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.
Perform additional duties as assigned by the Regulatory Affairs Manager.
Assists the business by reporting the status of regulatory affairs activities in various project meetings or upon request from other departments.
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 Skills & Experience: 4 years' experience in a similar role within the pharmaceutical industry Ability to grasp business and organisational awareness related to the understanding of the business and/or regulatory agency's authority, structure, and activities.
An understanding of both regulatory and scientific matters relating to human drug products.
Awareness of the legislation governing the approval of products.
Assist in conducting external liaison, negotiation, and/or collaboration with stakeholders.
Ability to grasp project management skills to plan and designate project resources, monitor progress, and keep stakeholders informed the entire way.
Strong problem-solving, trouble-shooting, and analytical skills, with the ability to create innovative workable solutions; proactive anticipation of needs, with the ability to foresee challenges and problems, and take action to prevent them.
Excellent written, verbal, and listening communication skills – produce well thought-out, professionally written correspondence free of grammatical and spelling errors; speaks with confidence, and clarity and is easily understood; active listening to effectively receive, interpret and analyse information.
Excellent technical writing skills, with the ability to write for a variety of audiences and gather and develop technical information to present in a clear and comprehensible format and design.
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, drivemeaningful 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 - 28 by Sam Wood is an online program designed to help Aussies get fit at home and live happier, healthier lives.
From guided workouts and expert-created meal plans to motivational resources, it's designed for people of all fitness levels.
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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