Manager of Product Compliance and Strategy

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $185,000
Job Title

Regulatory Affairs Manager - A Key Role in Ensuring Compliance and Commercial Success

The ideal candidate will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. As a Regulatory Affairs Manager, you will maximise client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of products.

Key Responsibilities
  • Liaise with clients and regulatory teams to ensure timely and effective regulatory submissions and approvals.
  • Manage regulatory assessments for early pipeline products and new technologies, working closely with cross-functional teams.
  • Develop and implement regulatory strategies to ensure compliance with Australian and New Zealand regulations.
  • Provide expert advice on regulatory matters, including product licensing, marketing, and post-approval requirements.
  • Lead and manage a team of Regulatory Consultants, promoting a positive team culture and achieving results through people.
Requirements
  • A minimum of 10 years' experience in regulatory affairs, preferably in prescription products or consulting.
  • Formal qualifications in science or a related field are essential.
  • The successful candidate will be recognised 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 leading regulatory assessments for early pipeline products and new technologies is required.
Benefits
  • Join a team of specialists who share knowledge and expertise daily.
  • Closely work with experienced Senior Managers, Associate Directors, and Directors with extensive Consulting experience.
  • A commitment to creating a culture where everyone feels valued and heard, with opportunities to build new skills and grow careers.
  • Flexible working options, including varying start and finish times, and hybrid working arrangements.

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