Regulatory Professional Leader

2 weeks ago

Sydney, New South Wales, Australia PharmaLex Full time

Your Role

We are seeking a skilled Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. In this role, you will be responsible for ensuring appropriate licensing, marketing, and regulatory compliance of clients' products. 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.

Your Expertise

  • You 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 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 and experience in new products, i.e., Category 1 and New Medicine Applications is required.
  • 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 skills and stakeholder management skills.
  • You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.

We Offer

  • You will become part of a team renowned as specialists in our field, sharing 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 a place where you can build new skills and capabilities and grow your career.
  • Our team adopts flexible working options such as varying start and finish times and hybrid working. We welcome experiences from other countries and settings.

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