Strategic Regulatory and Innovation Lead

7 days ago

Sydney, New South Wales, Australia beBeeManager Full time $130,000 - $170,000
Regulatory Affairs and R&D Manager Job Description

The Regulatory Affairs and R&D Manager is a critical role that leads and supports the team to ensure product registration approvals and market access.

  1. Manage and support the team to achieve product registration approvals/market access opportunities to allow business growth.
  2. Develop and deliver regulatory strategies efficiently and in line with business needs.
  3. Provide and oversee regulatory evaluation of new products, and/or existing product development to enable efficient market access.
  4. Manage preparation, submission and tracking of regulatory applications for a defined product portfolio.
  5. Develop and maintain all products dossier compliance to regulatory requirements.
  6. Liaise with internal project team to support their development and delivery of new products.
  7. Use problem solving and collaboration to resolve any identified deficiencies or regulatory issues in a solutions-oriented manner.
Key Responsibilities:
  • Support the development of regulatory policy priorities, company positions and stakeholder engagement plans.
  • Oversee and manage record keeping and documentation of all regulatory and scientific affairs matters.
  • Manage responses to correspondence received from regulatory authorities within an agreed priority and timeframe.
  • Maintain strong relationships with external agencies, suppliers or others.
  • Keep up-to-date with government legislation as it relates to regulatory affairs.
About the Role:

The successful candidate will be a qualified professional with experience in natural health medicines.

Key attributes that will support success in this role include self driven, results oriented with a positive outlook, exceptional planning skills prioritising work requirements to meet deadlines.

Requirements:
  • Exceptional analytical and problem solving skills, excellent attention to detail and a commitment to compliance processes.
  • Ability to communicate cross-functionally with different departments with different levels of expertise.
  • Proven experience organising and motivating others.
  • Strategic thinker with a solutions-oriented approach.
  • Excellent understanding of regulatory requirements and guidelines.
  • Excellent written and verbal communication skills with the ability to be persuasive and foster positive and credible relationships with stakeholders.

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