Regulatory Affairs Expert Leader

6 days ago

Sydney, New South Wales, Australia PharmaLex Full time

At PharmaLex, we are seeking an experienced Regulatory Affairs Professional to join our team in Australia.

Job Overview

This is a leadership role that requires a strong track record of regulatory work spanning the entire product lifecycle. You will lead a team of highly skilled Regulatory Consultants and be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of clients' products.

Key Responsibilities
  • Advise and support clients on regulatory submissions and approvals for products, including liaising with regulatory teams and third-party subject matter experts.
  • Liaise proactively and work collaboratively with global, regional, and local colleagues to achieve results through people and develop a positive team culture.
  • Lead regulatory assessments for early pipeline products and new technologies, demonstrating exceptional communication skills and stakeholder management skills.
  • Effectively project manage and deliver several projects at once, thriving on diversity and challenge.
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 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.
What We Offer
  • You will become part of a team renowned as specialists in our field, sharing knowledge and expertise with others every day.
  • 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.
  • The estimated salary for this position is AU$150,000 - AU$180,000 per annum, depending on experience.

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