Regulatory Affairs Expert

4 weeks ago

Sydney, New South Wales, Australia PharmaLex Full time

Your Role

We are seeking an experienced Regulatory Affairs professional to join our team at PharmaLex Australia. In this role, you will have the opportunity to work with a diverse range of clients in the pharmaceutical and healthcare sectors. Your primary objective will be to ensure regulatory compliance and maximize client commercial success by advising on and managing regulatory submissions and approvals for products.

Your Profile

  • You will have formal qualifications in science or a related field and a minimum of 10 years' experience working in regulatory affairs, either in industry or a consulting setting.
  • You will be recognized as a technical expert within the Australian regulatory environment, with a strong track record of regulatory work spanning the entire product lifecycle.
  • You will have experience leading regulatory assessments for early pipeline products and new technologies.
  • You will be a natural problem-solver, critical thinker, and have exceptional communication skills and stakeholder management skills.
  • You will thrive on diversity and challenge and be able to 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.
  • We are committed to creating a culture where everyone feels 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, including varying start and finish times and hybrid working.
  • We 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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