Regulatory Affairs Manager

2 days ago

Sydney, Australia Healthcare Professionals Group Full time

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.

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia Bausch + Lomb Full time

    Bausch + Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around...

  • Regulatory Affairs Manager

    3 weeks ago

    Sydney Central Business District, Australia Robert Half Full time

    Regulatory Affairs Manager for a top 10 Insurance Firm in Australia. Financial Services, Regulatory Affairs, Insurance The Company Multi-award-winning large insurance firm based in Sydney with an excellent, inclusive culture with best-in-class flexibility. The company have won awards for being one of the best places to work due to their wellness...

  • Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    Global rare diseases biopharmaceutical company with strong pipeline. Technological and innovative drug discovery. Patient-centred and highly collaborative team.International and exciting rare diseases portfolioInternal growth development opportunitiesHighly cooperative and diverse cultureThis global biopharmaceutical leader specialises in providing...

  • Regulatory Affairs Manager

    6 days ago

    Sydney, Australia PERSOLKELLY Full time

    If you are passionate about developing complementary medicines and nutritional supplements, this job is for you! **ABOUT THE ROLE**: PERSOLKELLY have an exciting opportunity for a Regulatory Affairs Manager to further their experience within the pharmaceutical industry. Our client is an established Pharmaceutical Manufacturer that specialises in...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    Benefits• Challenging new role joining an organisation that is growing.• Leadership position mentoring a small team• Great environment with friendly & hard working team • Competitive salary package + Bonus • Supportive work-life balanceAbout the companyJoin a renowned healthcare company dedicated to serving the medical and scientific community,...

  • Manager, Regulatory Affairs

    3 weeks ago

    Sydney, Australia NSW Government -icare Full time

    **Open to all icare offices** - **Can work in Parramatta, Sydney-CBD, Newcastle, Gosford or Wollongong**: - **12-month maternity leave role, supporting Regulatory Affairs engagement**: - **Hybrid/flexible working model, positive work culture & competitive salary** ***About the Role** 12-month maternity leave cover opportunity available to support the...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    Benefits Challenging new role joining an organisation that is growing. Leadership position mentoring a small team Great environment with friendly & hard working team Competitive salary package + Bonus Supportive work-life balanceAbout the companyJoin a renowned healthcare company dedicated to serving the medical and scientific community, providing...

  • Regulatory Affairs

    1 week ago

    Sydney, New South Wales, Australia 4C Recruitment Full time

    ASX listed complementary healthcare manufacturer Busy, project driven environment Western Sydney work closer to homeImmediate opening for Reg Affairs professional with experience in complementary healthcare sector and excellent experience and understanding of TGA compliance. Growing business offering a growing pipeline of new products.Key Responsibilities:...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia PERSOLKELLY Full time

    If you are passionate about developing complementary medicines and nutritional supplements, this job is for youABOUT THE ROLE:PERSOLKELLY have an exciting opportunity for a Regulatory Affairs Manager to further their experience within the pharmaceutical industry. Our client is an established Pharmaceutical Manufacturer that specialises in complementary...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, Australia Medella Life Full time

    Location- Sydney- Contact name: - Ethan Keating- Job ref: - 827- Published: - about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)** **Location: Hybrid - Sydney, Australia** **Key Responsibilities**: - **Regulatory Compliance**: - Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector,...

  • Regulatory Affairs

    1 week ago

    Sydney, New South Wales, Australia Evolvescientific Full time

    About The CompanyLocated at Macquarie Park, this international chemicals manufacturing company specializes in producing a variety of water and hygiene products tailored for the foodservice, food processing, hospitality, healthcare, and industrial sectors. The company prides itself on delivering highly effective, innovative, sustainable, and top-notch quality...

  • Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Hengandhurst Full time

    Regulatory Affairs & Quality Assurance Manager | Medical Devices | Sydney basedSydneyMedical Device / Medical Thrilling times for this fast-growing ANZ medical devices company with a wide, diversified and exiting portfolio. Highly collaborative and warm team.Diverse and growing portfolio across the ANZ market.Opportunity to join an expanding collaborative...

  • Manager, Regulatory Affairs

    2 months ago

    Sydney, Australia Rabobank Full time

    **About us** Rabobank is the world’s leading specialist in food and agribusiness banking. One of our key strengths lies in our people who have a deep understanding of agriculture and are committed to adding long-term value for clients. Our commitment to our employees and clients is at the heart of everything we do. At Rabobank our culture is unique,...

  • Regulatory Affairs Manager

    1 week ago

    Sydney, Australia KE Select Full time

    Part of the Leadership Team at DiaSorin - Excellent opportunity to take the next step in your career - Stand alone role looking after ANZ with some APAC responsibilities **About The Company** KE Select have partnered exclusively with DiaSorin to uncover their next Regulatory Affairs Manager for ANZ. DisSorin is the global leader in the Molecular Diagnostics...

  • Head of Regulatory Affairs

    3 weeks ago

    Sydney, Australia HAYS Full time

    Exciting opportunity for a Head of Regulatory Affairs in consumer goods **Your new company** A global company with cutting edge medicines and consumer goods based in Sydney looking for a head of regulatory affairs to join there team in ANZ. **Your new role** You will be responsible for supporting and leading all things related to regulatory operations to...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?:If you feel like you're a part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We have reimagined the most important aspects of our work lives, creating more flexibility than ever...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia Medella Life Full time

    Location- Sydney- Contact name: Ethan Keating Job ref: 827 Published:about 2 hours agoJob Title: Regulatory Affairs Specialist (12-month Contract)Location: Hybrid - Sydney, AustraliaKey Responsibilities:- Regulatory Compliance: Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a specific emphasis on IVDs....

  • Executive Manager, Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Westpac Banking Corporation Full time

    Executive Manager, Regulatory Affairs (ASIC Team) This role is a Parental Leave Cover Role for a 12month period Sydney or Melbourne based hybrid working Incredible opportunity to join Westpac's Regulatory Affairs teamHow will I help?The Executive Manager, Regulatory Affairs is responsible for leading regulatory engagement (with an ASIC and BCCC focus) in...

  • Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia KE Select Full time

    Part of the Leadership Team at DiaSorin Excellent opportunity to take the next step in your career Stand alone role looking after ANZ with some APAC responsibilities About The Company KE Select have partnered exclusively with DiaSorin to unveil their next Regulatory Affairs Manager for ANZ. DiaSorin is a dominant player in the Molecular Diagnostics...

  • Executive Manager, Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia EFinancialCareers Ltd. Full time

    Executive Manager, Regulatory Affairs Westpac Banking Corporation Sydney, Australia Executive Manager, Regulatory Affairs Westpac Banking Corporation Sydney, Australia Posted 2 days ago Permanent Competitive Executive Manager, Regulatory Affairs Job Description Permanent role. Sydney or Melbourne based - hybrid working. Great opportunity to join Westpac's...