Regulatory Compliance Officer

2 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Job Title:

Regulatory Support Specialist


Job Description:">

This role involves providing regulatory support to international country and/or cluster Regulatory teams. The successful candidate will work across portfolio phases from initial applications, commercial lifecycle through to product withdrawal.

">Key Responsibilities:">
  • Identify key regulatory requirements for in-scope submission categories
  • Author and deliver high-quality documents ready for local submissions
  • Quality review and approval of Dossiers provided by Hub Submission/Dossier Managers
  • Implement portfolio execution efficiencies and identify quality and compliance issues
">

The selected candidate will partner closely with Country Regulatory Strategists and Hub Submission/Dossier Managers to ensure timely, high-quality submissions and sustained compliance. They will act as an initial point of contact for assigned countries/clusters and key stakeholders.

">Accountabilities:">
  • Ensure timely delivery of local dossier components
  • Provide regulatory support for cross-functional activities assigned to local affiliates
  • Support local audit readiness activities and country regulatory strategists with country cross-functional meetings
  • Perform quality review/approval of the Dossier build Table of Contents provided by Hub Submission/Dossier Managers
">

As a key member of the team, this specialist will support RIO and International Regional Leadership partnering with Submission Hubs for international commercial discussions. They will also lead regulatory support to countries/clusters with challenging internal and external constraints.

">Required Skills and Qualifications:">
  • Strong understanding of regulatory requirements and compliance
  • Excellent document authoring and reviewing skills
  • Ability to work independently and collaboratively within a team
  • Strong analytical and problem-solving skills
">

Additional qualifications include a bachelor's degree in a relevant field or equivalent experience. This position requires strong communication and interpersonal skills, with the ability to work effectively in a fast-paced environment.

">Benefits:">

Enjoy a dynamic and supportive work environment, competitive compensation package, and opportunities for professional growth and development.

">Others:">

At our company, we value diversity and inclusion, and strive to create a workplace where everyone feels valued and respected.

"],

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