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Regulatory Affairs Manager

vor 3 Monaten

Sydney, Österreich Healthcare Professionals Group Vollzeit

Pharmaceuticals & Medical Devices (Healthcare & Medical)

Full time

Competitive Salary + Super + Great Benefits

Benefits
• Work with a collaborative Regulatory Affairs team
• Global biopharmaceutical company
• Flexible work arrangements & excellent benefits

About the Company
This medium specialty global biopharmaceutical company is renowned for its expertise and is dedicated to helping people build healthy families and live better lives.

About the Opportunity
As the Regulatory Affairs Manager, you will play a crucial role in managing regulatory activities, submissions, and compliance efforts. Reporting to the Senior Regulatory lead you will collaborate with global regulatory teams and key stakeholders, ensuring regulatory success and making a significant impact on the company's business and market presence. This role is vital to our client's success as it ensures that all regulatory activities are conducted efficiently and effectively, allowing the company to bring innovative healthcare products to market and ultimately improve patient outcomes.
Your contributions as the Regulatory Affairs Manager will directly impact the company's ability to launch new products, maintain market presence, and navigate regulatory challenges effectively. You will play a crucial role in driving business growth and maintaining a competitive edge in the global market.

Duties
As the Regulatory Affairs Manager, your responsibilities will include:
• Managing and preparing comprehensive responses and mandatory reports for the TGA, encompassing diverse submissions, Periodic Safety Update Reports and more.
• Developing and refining Product Information, Consumer Medicine Information, labels, Certified Product Details (or equivalent), and other critical documentation, ensuring accuracy and compliance with regulatory standards.
• Collaborating closely with internal teams to assist in preparing and submitting pricing applications, contributing to strategic pricing decisions and market access.
• Acting as a key liaison with international regulatory colleagues, coordinating efforts with global regulatory strategies.
• Taking charge of the preparation and presentation of labelling and packaging mock-ups for regulatory submission, utilising internal artwork management systems and overseeing the creation and approval processes.
• Ensuring thorough maintenance of all new and existing products on the ARTG, managing updates, registrations, and regulatory compliance.
• Overseeing and managing allocated device regulatory submissions, responses, and notifications to the TGA under the supervision of the Senior Manager, maintaining up-to-date technical files and regulatory compliance for devices.
• Maintaining the integrity and accuracy of the Global Regulatory Affairs Database ensuring efficient data management and compliance with internal and external regulatory standards.
• Proactively staying updated with government legislation and regulatory changes as they relate to regulatory affairs, implementing necessary measures to ensure ongoing compliance and regulatory excellence.

Skills and Experience
• 5 Years of Regulatory Affairs Experience in a similar Regulatory Affairs role within the pharmaceutical, focusing on prescription medicines and/or medical devices.
• A graduate degree in a medical or related is preferred, providing a strong foundation in healthcare and regulatory principles.
• Excellent oral and written communication skills and a meticulous attention to detail.
• The ability to deliver results to tight deadlines without compromising quality or accuracy
• Demonstrated analytical skills, allowing you to interpret regulatory guidelines, assess risks, and develop strategic regulatory plans.

Culture
Our client fosters a collaborative and empowering culture, promoting innovation and professional growth.

How to Apply
Click "apply" or contact Gemma Staddon, Specialist Manager, on gstaddon@hpgconnect.com for a confidential discussion.

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