Regulatory Affairs Director

5 days ago

Sydney, New South Wales, Australia PharmaLex Full time

Your Role

We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. 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 client products. 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. You will also liaise proactively and work collaboratively with global, regional, and local colleagues.

Your Profile

  • 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 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 skills and stakeholder management skills.
  • You thrive on diversity and challenge and can effectively project manage and deliver several projects at once.

We Offer

  • By joining the PharmaLex 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 all build new skills and capabilities and grow our careers.
  • 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.

Please submit your application, including a cover letter. Applicants must be based in Australia and have full working rights.

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