Regulatory Affairs Project Lead
2 months ago
We are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our Regulatory Affairs team, you will be responsible for leading the development and implementation of regulatory strategies for a portfolio of products.
You will work closely with cross-functional teams to ensure that regulatory submissions are of high quality and meet the required standards. Additionally, you will provide regulatory guidance and expertise to other functions within the company.
This is an excellent opportunity for a motivated and experienced Regulatory Affairs professional to take on a challenging role and contribute to the success of our team.
Responsibilities- Lead the development and implementation of regulatory strategies for a portfolio of products.
- Collaborate with cross-functional teams to ensure that regulatory submissions are of high quality and meet the required standards.
- Provide regulatory guidance and expertise to other functions within the company.
- Ensure that all regulatory work is undertaken in compliance with local regulations and corporate standards.
- Maintain a good understanding of the regulatory environment and guidelines.
- Bachelor's Degree in Pharmacy or Science or a related field.
- Extensive previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand.
- Demonstrated strong technical expertise working with the TGA and Medsafe.
- Natural growth mindset - you thrive on challenge and see failure as a springboard for growth and developing your abilities.
- Positive can-do attitude and are self-motivated with a sense of urgency.
- Excellent verbal and written communication skills.
- Strong project management skills, including critical thinking and problem solving, negotiation, time management, and risk management.
- Demonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver results.
- Extremely strong ethical values.
Johnson & Johnson is a global healthcare leader driven by a passion to change the trajectory of health for humanity. We believe in the power of collaboration and are committed to working with others to improve the health of people around the world.
We are a company that is driven by innovation, and our products and services are designed to meet the needs of healthcare professionals and patients. We are committed to making a positive impact on the lives of people everywhere.
-
Regulatory Affairs Specialist
2 months ago
Sydney, New South Wales, Australia Johnson & Johnson Full timeRegulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...
-
Regulatory Affairs Leadership Specialist
1 month ago
Sydney, New South Wales, Australia Johnson & Johnson Full timeCompany OverviewJanssen, a part of Johnson & Johnson, is a global healthcare leader driven by a dedication to innovation and customer focus.Job SummaryWe are seeking an experienced Regulatory Affairs Project Manager or Senior Regulatory Affairs Associate to join our team in North Ryde (open to other states). As a key member of the Regulatory Affairs team,...
-
Regulatory Affairs Strategist
4 weeks ago
Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Strategist to join our high-performing regulatory team at Stryker Australia Pty Ltd.Job DescriptionThis senior role will focus on preparing and submitting device registration applications, including complex submissions such as Class III and/or TGA Conformity Assessment applications. You will...
-
Senior Regulatory Affairs Specialist
4 weeks ago
Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full timeRegulatory Affairs Role at Stryker Australia Pty LtdWe are seeking a highly experienced Senior Regulatory Affairs Specialist to join our team in Melbourne, Australia. This is an exciting opportunity for a talented professional to work with a leading global medical device company.The successful candidate will have a minimum of 5 years' experience in...
-
Regulatory Affairs Specialist
2 months ago
Sydney, New South Wales, Australia Colgate-Palmolive Company Full timeAbout the Role:We are seeking a Regulatory Affairs Associate to join our team at Colgate-Palmolive Company. As a key member of our Regulatory Affairs function, you will be responsible for delivering efficient and effective regulatory strategy solutions to support the optimal business outcomes for our South Pacific subsidiaries.Key Responsibilities: ...
-
Sydney, New South Wales, Australia Careerlink People Solutions Full timeCareerlink People Solutions is partnering with BiomeBank to present a unique opportunity for an experienced regulatory affairs professional.BiomeBank, a clinical stage biotechnology company, aims to revolutionize disease treatment by restoring gut microbial ecology. With the recent announcement of the first regulatory approval for a donor-derived microbiome...
-
Sydney, New South Wales, Australia PharmaLex Full timeWe are seeking a highly experienced Regulatory Professional to lead our team in Australia.Company OverviewPharmaLex is a renowned specialist in the field of pharmaceutical regulatory consulting. Our team of experts provides high-quality services to clients across various industries.About the RoleThis role offers an exciting opportunity to work with a broad...
-
Regulatory Affairs Expert
1 month ago
Sydney, New South Wales, Australia Johnson & Johnson Full timeCompany OverviewJanssen, a pharmaceutical company dedicated to developing life-changing treatments, is seeking a skilled Senior Regulatory Affairs Associate to join its team. With a focus on product innovation and customer satisfaction, Janssen strives to deliver exceptional outcomes for patients and customers.Salary: $120,000 - $160,000 per annum, based on...
-
Regulatory Affairs Specialist
4 weeks ago
Sydney, New South Wales, Australia Stryker Full timeBased in Australia, this Senior Regulatory Affairs Associate role at Stryker presents an exciting opportunity to join a high-performing team in the medical device industry. With a strong focus on regulatory compliance, you will be responsible for preparing and submitting device registration applications, including complex submissions such as Class III and/or...
-
Regulatory Affairs Professional
4 weeks ago
Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full timeAbout Device Technologies Australia Pty Ltd...Device Technologies Australia Pty Ltd is a leading supplier of medical solutions to hospitals and healthcare professionals in Australia, New Zealand, and Asia.We have been dedicated to improving patients' lives through cutting-edge technology and services since 1992. Our reputation for quality, dedicated service,...
-
Sydney, New South Wales, Australia PharmaLex GmbH Full timeWe are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia.About UsPharmalex is a leading service company for the Pharmaceutical Industry globally, specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.Your JobIn this role, you will...
-
Regulatory Affairs Director
4 weeks ago
Sydney, New South Wales, Australia On Q Recruitment Full timeAbout On Q RecruitmentOn Q Recruitment is proud to partner with an ASX-listed medical device company in their search for a Senior Manager – Global Regulatory Affairs & Quality Assurance.Job OverviewThis is a permanent, full-time position that offers excellent work-from-home flexibility. As a key member of the leadership team, you will play a pivotal role...
-
Regulatory Affairs Engineer Opportunity
4 weeks ago
Sydney, New South Wales, Australia ResMed Full timeResMed is committed to shaping the future of healthcare by creating innovative medical technology solutions. Our company overview highlights our focus on improving millions of lives, fostering a diverse and inclusive culture, and promoting individual expression in the workplace.Estimated SalaryAverage salary for this role in Sydney ranges from AU$60,000 to...
-
Regulatory Affairs Specialist
4 weeks ago
Sydney, New South Wales, Australia MidCoast Council Full timeAbout the RoleWe are seeking a skilled Regulatory Affairs Specialist to join our Environmental Health and Regulatory Services team.In this role, you will investigate and address complaints using risk-based principles, involving matters of high significance related to environmental harm, public health and safety, and legislative non-compliance.You will engage...
-
Sydney, New South Wales, Australia Reckitt Benckiser Australia Full timeAbout the RoleWe are seeking an experienced Regulatory Affairs Associate to join our team at Reckitt Benckiser Australia. As a key member of our regulatory department, you will be responsible for ensuring our hygiene products comply with all relevant regulations and guidelines.This is an exciting opportunity to work with a global team that shares your...
-
Regulatory Affairs Graduate Engineer Position
4 weeks ago
Sydney, New South Wales, Australia ResMed Full timeAbout ResMedWe are a global leader in the development of innovative medical devices for the diagnosis, treatment, and management of sleep and respiratory disorders. Our vision is to make every breath count by delivering high-quality products that improve patient outcomes.Salary Range:$70,000 - $90,000 per annum (dependent on experience)Job Description:The...
-
Regulatory Affairs Specialist
1 month ago
Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full timeAbout UsAt Device Technologies Australia Pty Ltd, we have a reputation for delivering high-quality medical solutions to hospitals and healthcare professionals across Australia, New Zealand, and Asia.The OpportunityWe are seeking a skilled Regulatory Affairs Specialist to join our team. This is a critical role that involves working closely with internal and...
-
Medical Affairs Senior Lead
1 month ago
Sydney, New South Wales, Australia Thermo Fisher Scientific Full timeMedical Affairs Senior LeadEstablish and lead key opinion leader relationships to drive the clinical adoption of Thermo Fisher Scientific's EXENT products in the Asia/Pacific market.Contribute to the development of scientific, publication, and health economic strategies.Gather and analyze internally generated and externally generated data to create...
-
Sydney, New South Wales, Australia Reckitt Benckiser Australia Full timeWe are Reckitt, a leading global company dedicated to creating a cleaner, healthier world.Our purpose is to protect, heal and nurture through our portfolio of world-renowned brands. We're committed to making access to high-quality hygiene, wellness and nutrition a right, not a privilege.The Role:This Regulatory Associate position offers a unique opportunity...
-
Public Affairs and Reputation Manager
2 weeks ago
Sydney, New South Wales, Australia Montu Full timeWe are seeking an experienced Public Affairs and Communications professional to join our team at Montu in Australia. This is a fantastic opportunity to develop and execute public affairs strategies, foster relationships with key stakeholders, and enhance Montu's reputation.### Job OverviewThe Public Affairs and Communications Lead plays a critical role...
