Regulatory Lead

2 weeks ago

Australia beBeeExpertise Full time $150,000 - $200,000
Job Description

Lead Regulatory Expert - Complex Products

This leadership role requires a seasoned professional to develop and implement regulatory strategies for complex products.

  • The ideal candidate will have extensive knowledge of regulatory affairs, strong understanding of consultancy, strategic planning, and team leadership principles.
  • Able to work in a dynamic and collaborative environment with excellent communication and interpersonal skills.

About the Role

Developing product strategies for biologics, vaccines, and advanced therapies is a critical aspect of this position.

  • Mentoring and developing a high-performing team to drive success.
  • Liaising with clients and representing them in agency meetings with confidence.

Key Responsibilities

  • Authorizing and reviewing high-impact regulatory documents.
  • Navigating FDA, EMA, and ICH guidelines with ease.

Requirements

  • Mid-Senior level professional with a minimum of ten years of experience in regulatory submissions and agency interactions.
  • Ability to adapt to changing regulations and priorities.
  • Strong problem-solving and analytical skills.

What We Offer

An opportunity to work with a global regulatory consultancy seeking experienced professionals to join our team.

Why You'll Thrive Here

  • Cultivating expertise in CMC development and regulatory affairs.
  • Fostering a culture of collaboration and innovation.

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