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Regulatory Affairs Leader for Pharmaceutical Products
1 month ago
PharmaLex Australia is seeking an experienced Regulatory Affairs professional to lead our team in delivering regulatory solutions for pharmaceutical clients. This role offers a unique opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors.
SalaryThe estimated salary for this position is AU$120,000 - AU$180,000 per annum, depending on experience.
About the RoleWe are looking for a highly skilled Regulatory Affairs professional with a strong track record of regulatory work spanning the entire product lifecycle. In this role, you will advise, support and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams and third-party subject matter experts.
Key Responsibilities- Liaise proactively and work collaboratively with global, regional and local colleagues.
- Manage regulatory assessments for early pipeline products and new technologies.
- Develop a positive team culture and achieve results through people.
- Project manage and deliver several projects at once.
- Formal qualifications in science or similar field and a minimum of 10 years' experience working in regulatory affairs.
- Recognized as a technical expert within the Australian regulatory environment.
- Extensive experience in prescription medicines Regulatory Affairs within Australia and New Zealand.
- Experience in new products, i.e., Category 1 and New Medicine Applications.
- Natural problem-solver, critical thinker, commercially minded, and exceptional communication skills and stakeholder management skills.
- Work closely with experienced Senior Managers, Associate Directors and Directors who have extensive consulting experience.
- Flexible working options such as varying start and finish times and hybrid working.
- Diverse workplace welcoming experiences from other countries and settings.
PharmaLex Australia is renowned as specialists in our field, sharing knowledge and expertise with others every day. We are committed to creating a culture where we all feel valued and heard, and a place where we can all build new skills and capabilities and grow our careers.
