Regulatory Affairs Director

1 day ago

Sydney, New South Wales, Australia ENG Con Full time
{"title": "Regulatory Affairs Director", "content": "Job Summary

We are seeking an experienced Regulatory Affairs Director to join our team at ENG Con. As a key member of our Pharmaceutical Regulatory Consulting team, you will be responsible for ensuring the regulatory compliance of client products and maximizing their commercial success.

Key Responsibilities:

  • Lead regulatory submissions and approvals for products, including liaising with clients, regulatory teams, and third-party subject matter experts.
  • Advise and support clients on regulatory matters, including licensing, marketing, and product maintenance.
  • Manage a team of highly skilled Regulatory Consultants and contribute to the development of a positive team culture.

Requirements:

  • Formal qualifications in science or a similar field and a minimum of 10 years' experience working in regulatory affairs 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, including new products such as Category 1 and New Medicine Applications.

About Us

ENG Con is a leading service company for the Pharmaceutical Industry globally, specializing in all aspects of drugs and medical devices approval, market development, and effective product maintenance. We offer a range of flexible working options and a diverse workplace that welcomes experiences from other countries and settings.

", "lang_code": "en-US"}

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