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Regulatory Affairs Expert

2 months ago

Sydney, New South Wales, Australia Pharmalex Full time

About the Role

We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. As a Senior Manager, Regulatory Affairs, you will work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors.

Your Key Responsibilities

  • Maximize client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client's products.
  • Advise, support, and manage regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts.
  • 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.
  • You have extensive experience leading regulatory assessments for early pipeline products and new technologies.
  • 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 Us

  • We are a leading service company for the Pharmaceutical Industry globally, specialized in all aspects of drugs and medical devices approval, market development, and effective product maintenance.
  • We offer a range of flexible working options, including varying start and finish times and hybrid working.
  • We are a diverse workplace and welcome experiences from other countries and settings.