Regulatory Affairs Director
3 weeks ago
We are seeking an experienced Regulatory Affairs professional to join our team in Australia.
About the RoleThis is an exciting opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors.
As a Regulatory Affairs Director, you will be responsible for ensuring appropriate licensing, marketing, and regulatory compliance of client products.
You will advise, support, and manage regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts.
As a Team Lead, you will have a team of highly skilled Regulatory Consultants reporting to you, and together you will be committed to achieving the best outcomes for our clients and the patients we serve.
About YouYou have formal qualifications in science or a similar field and a minimum of 10 years' experience working in regulatory affairs for prescription products in industry or a consulting setting.
You are 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, including new products such as Category 1 and New Medicine Applications, is required.
You have extensive experience leading regulatory assessments for early pipeline products and new technologies.
You have worked in leadership roles, demonstrating the ability to achieve results through people and develop a positive team culture.
You are a natural problem-solver, critical thinker, commercially minded, and have exceptional communication and stakeholder management skills.
You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.
About UsBy joining the Pharma Lex Australia team, you will become part of a team renowned as specialists in our field.
Sharing knowledge and expertise with others is part of every day.
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 we all feel valued and heard, and a place where we can build new skills and capabilities and grow our careers.
Our head office is based in St Leonard's, Sydney, NSW, Australia.
Ideally, candidates will be Sydney-based; however, Melbourne, Canberra, or Brisbane locations may be considered.
We offer a range of flexible working options such as varying start and finish times and hybrid working.
We are a diverse workplace and welcome experiences from other countries and settings.
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