Strategic Product Development Specialist

5 days ago

Perth, Western Australia beBeeConsultant Full time $90,000 - $120,000

Regulatory Affairs Expert Sought

We are seeking an experienced Regulatory Affairs Principal Consultant to drive strategic development of complex products in the global market.

This role offers the opportunity to lead cross-border programs, author high-impact regulatory documents and represent clients in agency meetings.

The ideal candidate will have deep expertise in CMC development and regulatory affairs, backed by a minimum of ten years of experience in regulatory submissions and agency interactions.

A strong background in consultancy, strategic planning and team leadership is essential for success.

Key responsibilities include:

  • Developing product strategies for biologics, vaccines and advanced therapies
  • Navigating FDA, EMA and ICH guidelines
  • Leading cross-border programs and representing clients in agency meetings

Apply today and join a dynamic and collaborative environment where you can leverage your expertise to drive business growth.

Key Requirements

  • Minimum 10 years' experience in regulatory affairs and submissions
  • Deep expertise in CMC development
  • Strong knowledge of FDA, EMA and ICH guidelines
  • Excellent communication and project management skills

What We Offer

  • Opportunity to shape regulatory strategy for complex products
  • Chance to mentor and develop a high-performing team
  • Collaborative work environment with a dynamic team

Seniority Level: Mid-Senior level
Employment Type: Full-time
Job Function: Science
Industries: Business Consulting and Services

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