Product Registration and Compliance Specialist

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $95,000 - $125,000
Regulatory Affairs and R&D Leadership

BioMedica's dedication to quality, purity, and efficacious natural medicine products underscores the importance of strategic planning and compliance in achieving product registration approvals and market access.

The Regulatory Affairs and R&D Manager will spearhead a team to ensure seamless product registration approvals and market access opportunities through expertly crafted regulatory strategies and diligent compliance efforts.

The ideal candidate will possess excellent leadership skills, with the ability to manage and motivate cross-functional teams towards shared goals. They will also be proficient in developing and delivering robust regulatory strategies, providing regulatory evaluation of new products, and overseeing dossier compliance.

A strong network of internal stakeholders is crucial for success in this role. The Regulatory Affairs and R&D Manager will work closely with various teams to support new product development, drive business partnerships, and foster a culture of innovation and excellence.

This position requires an individual who can think critically, analyze complex information, and provide informed solutions to regulatory challenges. They must also be able to communicate effectively with both technical and non-technical stakeholders, ensuring that all parties are aligned and working towards common objectives.

In addition to their technical expertise, the successful candidate will demonstrate exceptional interpersonal skills, including active listening, empathy, and conflict resolution. They will also be able to adapt quickly to changing priorities and circumstances, maintaining a calm and professional demeanor even in high-pressure situations.

The ultimate goal of this position is to contribute significantly to BioMedica's growth and success by driving innovative solutions, improving processes, and fostering a collaborative work environment.

Key Responsibilities:

  • Manage and motivate cross-functional teams to achieve product registration approvals/market access opportunities.
  • Develop and deliver robust regulatory strategies, providing regulatory evaluation of new products and overseeing dossier compliance.
  • Drive business partnerships with various divisions of the business, fostering a culture of innovation and excellence.
  • Support new product development, working closely with internal stakeholders to ensure seamless product launches.
  • Liaise with internal teams to support regulatory policy priorities and stakeholder engagement.

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