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Regulatory Affairs Director
1 month ago
We are a leading consulting company, specialized in regulatory affairs for the pharmaceutical industry. Our team of experts has extensive experience in all aspects of drug and medical device approval.
Salary
The estimated salary for this position is AU$140,000 - AU$180,000 per year, depending on experience. We offer a range of flexible working options, including hybrid work arrangements.
Job Description
In this role, you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective is to maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of their products.
As a Senior Regulatory Consultant, you will advise, support, and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams, as well as third-party subject matter experts. You will also be responsible for proactively communicating with global, regional, and local colleagues, both internally and externally.
Required Skills and Qualifications
To be successful in this role, you will need to have formal qualifications in science or a similar field, and a minimum of 10 years' experience working in regulatory affairs, either for prescription products in industry or a consulting setting.
You should be recognized as a technical expert within the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle. Extensive experience in prescription medicines regulatory affairs within Australia and New Zealand is required, as well as experience in new products, such as Category 1 and New Medicine Applications.
Additionally, you should have experience leading regulatory assessments for early pipeline products and new technologies, and have worked in leadership roles, demonstrating the ability to achieve results through people and develop a positive team culture.
Benefits
We offer a dynamic and challenging work environment, where you will have the opportunity to share your knowledge and expertise with others. You will work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience.
We are committed to creating a culture where everyone feels valued and heard, and we offer a range of benefits, including flexible working options, professional development opportunities, and a competitive salary package.
