Senior Regulatory Professional

1 week ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $120,000 - $150,000
Regulatory Affairs Manager Role

Commercial Eyes is seeking a highly skilled and experienced Regulatory Affairs Manager to join our team.

This key role involves managing a portfolio of projects, overseeing direct reports, and ensuring the delivery of high-quality services to clients. The ideal candidate will have extensive experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.

  • Key Responsibilities:
  • Foster relationships with business units to support cross-functional collaboration and drive innovation.
  • Provide high-quality work that contributes to client satisfaction and loyalty.
  • Work closely with senior managers on strategic matters and provide relevant insights to the consulting leadership team.
  • Assist with business unit management, including the development and implementation of strategic plans.
  • Provide specialist knowledge, advice, and guidance on best practices and develop resources to enable the delivery of high-quality RQC services.
  • Review and quality-check applications, regulatory, quality, and compliance documentation as required.
Requirements
  • Qualifications:
  • Completed studies in pharmaceutical sciences or related scientific fields.
  • Post-graduate qualifications in a relevant discipline are preferable.
  • Proven record of consulting experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
  • Comprehensive knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures.
  • Experience in technical/medical writing, particularly associated with therapeutic product requirements.
  • Experience in the review, critical evaluation, and presentation of clinical and quality data.
  • Financial acumen and demonstrated business development skills.
  • Proven experience in people supervision, mentoring, and leadership.
What We Offer
  • Benefits:
  • A collaborative culture where you're valued and supported.
  • Diverse team members from various backgrounds and experiences.
  • Access to career development opportunities within Commercial Eyes and the ProductLife Group.
  • A wellbeing allowance and paid wellbeing day to focus on your physical and mental health.
  • An additional birthday day off to celebrate your special day.

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