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Regulatory Affairs Director

2 months ago

Sydney, New South Wales, Australia ENG Con Full time
About the Role

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 play a critical role in ensuring the commercial success of our clients by ensuring appropriate licensing, marketing, and regulatory compliance of their products.

Key Responsibilities
  • Maximize client commercial success by ensuring regulatory compliance of client products
  • Advise and support clients on regulatory submissions and approvals for products
  • Liaise with clients, regulatory teams, and third-party subject matter experts
  • Lead a team of highly skilled Regulatory Consultants in achieving the best outcomes for clients and patients
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
  • Experience leading regulatory assessments for early pipeline products and new technologies
  • Leadership experience, demonstrating the ability to achieve results through people and develop a positive team culture
  • Natural problem-solver, critical thinker, commercially minded, and exceptional communication and stakeholder management skills
What We Offer
  • Opportunity to work with a team renowned as specialists in our field, sharing knowledge and expertise with others
  • Commitment to creating a culture where everyone feels valued and heard, and a place where we can build new skills and capabilities and grow our careers
  • Flexible working options, including varying start and finish times and hybrid working
  • Diverse workplace welcoming experiences from other countries and settings