Regulatory Affairs Director for Pharmaceutical Consultancy

5 days ago


Sydney, New South Wales, Australia PharmaLex Full time

Overview

We are seeking a highly experienced Regulatory Affairs Director to join our Pharmaceutical Consulting team in Australia.

This is an exceptional opportunity to lead a team of skilled Regulatory Consultants and work with a diverse range of clients, primarily in the pharmaceutical and healthcare sectors.

Your primary objective will be to maximize client commercial success by 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 and regulatory teams, as well as third-party subject matter experts.

In this role, you will proactively collaborate with global, regional, and local colleagues to achieve the best outcomes for our clients and ultimately the patients we serve.

About You

  • 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.
  • 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.

About the Role

  • The estimated salary for this position is $120,000 - $180,000 per annum, depending on experience.
  • The successful candidate will be based in Sydney, with options to work remotely or from other locations in Australia.
  • You will have the opportunity to work closely with experienced Senior Managers, Associate Directors, and Directors who have extensive consulting experience.
  • We offer a range of flexible working options, including varying start and finish times and hybrid working.

What We Offer

  • We are committed to creating a culture where all employees feel valued and heard, and where everyone can build new skills and capabilities and grow their careers.
  • We welcome applications from candidates with 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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