Strategic Regulatory Affairs Specialist

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $220,000
Regulatory Affairs Leadership Role

This is a 12-month contract position providing regulatory leadership of a portfolio of products and supporting business growth.


Key Responsibilities:
  • Lead a product portfolio to develop and implement regulatory strategies, manage local regulatory submissions for Australia and New Zealand, and drive business growth.
  • Collaborate with global, regional, and local colleagues to ensure timely and high-quality regulatory submissions and labelling.
  • Participate in cross-functional project teams to lead regulatory discussions, develop pipeline strategies, and optimize launch excellence.
  • Lead departmental projects and initiatives, including TGA/Medsafe consultations and global/regional Regulatory Affairs projects.
  • Provide regulatory guidance and expertise to other functions within the organization to deliver outcomes.
  • Ensure all relevant work is undertaken in compliance with local regulation requirements and corporate standards.

Qualifications and Skills:
  • 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 the TGA and Medsafe.
  • A natural growth mindset, positive attitude, and self-motivation are essential for success in this role.
  • Excellent communication, stakeholder management, and negotiation skills are required.
  • Strong ethical values and a commitment to compliance are necessary.

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