Senior Regulatory Affairs Professional

7 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878
Regulatory Affairs Specialist Position

We are seeking a highly skilled Regulatory Affairs Specialist to lead our portfolio of products in Australia and New Zealand.

About the Role

The successful candidate will provide regulatory leadership, plan strategies, and manage local submissions for the region.

Key Responsibilities:
  • Lead product portfolio planning and regulatory strategy development
  • Liaise with global, regional, and local colleagues on application management throughout submission and evaluation processes
  • Collaborate with cross-functional project teams to lead regulatory discussions and develop pipeline strategies for optimal launch excellence
  • Manage ad-hoc departmental projects and initiatives, including regulatory consultations and projects initiated by the global/regional Regulatory Affairs
  • Provide regulatory guidance and expertise to other functions within the organization
  • Ensure compliance with local regulation requirements and corporate standards
Requirements

To be successful in this role, you will need:

  • A Bachelor's Degree in Pharmacy or Science or related field
  • Previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand, including Category 1 and New Medicine Applications
  • Demonstrated strong technical expertise working with regulatory authorities
  • A natural growth mindset and ability to thrive in a challenging environment
  • Positive attitude, self-motivation, and sense of urgency
  • Good verbal and written communication skills
  • Ability to lead from the front, connect with stakeholders, shape outcomes, and deliver results
  • Solid stakeholder management and negotiation skills, and achieving business deliverables
  • Strong ethical values
What We Offer

We offer a dynamic work environment that fosters innovation, customer focus, and organisational excellence. Our team is committed to developing and marketing treatments that make a real difference.

We believe in connecting our expertise with others to find transformational solutions. We collaborate with the world for the health of everyone in it.

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