Regulatory Affairs Director for Pharmaceutical Products

24 hours ago


Sydney, New South Wales, Australia PharmaLex Full time

We are seeking a highly experienced Regulatory Professional to lead our team in Australia.

Company Overview

PharmaLex is a renowned specialist in the field of pharmaceutical regulatory consulting. Our team of experts provides high-quality services to clients across various industries.

About the Role

This role offers an exciting opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective will be to ensure appropriate licensing, marketing, and regulatory compliance of client 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 reporting into you, working collaboratively to achieve the best outcomes for our clients and ultimately the patients we serve.

Key Responsibilities
  • To provide expert guidance on regulatory affairs for prescription medicines within Australia and New Zealand.
  • To lead regulatory assessments for early pipeline products and new technologies.
  • To develop and maintain strong relationships with clients, regulatory teams, and third-party subject matter experts.
  • To manage multiple projects simultaneously, ensuring timely delivery and exceeding client expectations.
Requirements
  • Minimum 10 years' experience in regulatory affairs, either in industry or consulting.
  • Strong technical expertise within the Australian regulatory environment.
  • Demonstrated leadership skills, achieving results through people and developing a positive team culture.
  • Natural problem-solver, critical thinker, commercially minded, and exceptional communication skills.
What We Offer
  • A competitive salary package: AU$120,000 - AU$180,000 per annum, depending on experience.
  • A collaborative and dynamic work environment, with opportunities for professional growth and development.
  • A range of flexible working options, including varying start and finish times and hybrid working arrangements.


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