Regulatory Affairs Specialist

3 weeks ago

Sydney, New South Wales, Australia PharmaLex Full time

Regulatory Affairs Role Overview

We are seeking an experienced Regulatory Affairs Professional to join our Pharmaceutical Regulatory Consulting team in Australia.

In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and health care sectors, to ensure licensing, marketing, and regulatory compliance of products.

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.

As a Team Lead, you will have a team of highly skilled Regulatory Consultants that will report into you and together you will be committed to getting the best outcomes for our clients and ultimately the patients we serve.

Key Responsibilities

  • Minimum of 10 years' experience working in regulatory affairs either for prescription products in industry or a consulting setting.
  • 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.
  • Experience leading regulatory assessments for early pipeline products and new technologies.
  • Leadership roles demonstrating the ability to achieve results through people and develop a positive team culture.

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.
  • A culture where you will feel valued and heard, and a place where you can build new skills and capabilities and grow your career.
  • A range of flexible working options, including varying start and finish times and hybrid working.
  • A diverse workplace welcoming 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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