Director, Global Regulatory Affairs leading Protara's ex - US regulatory strategy and operational execution for clinical studies in oncology, cell and gene therapy, and rare diseases.
About the role
- Regulatory Coordinator supporting compliance in Docklands, Australia. Engaging with regulators and coordinating compliance activities between operations, legal, and authorities.
Responsibilities
- Provide regulatory compliance leadership for operations. Act as the focal point for regulator engagement, issue management, advocacy, and continuous improvement—ensuring alignment with legal requirements, company standards (including OIMS), and business objectives.
- Focal point in regulatory compliance activities, including inspections, investigations and meetings, providing advice to internal stakeholders regarding regulatory deliverables.
- Maintain and monitor compliance programs, tools, and processes to support oversight of SSHE compliance.
- Coordinate timely regulatory correspondence (notifications, license applications/amendments etc.) in collaboration with internal stakeholders.
- Identify regulatory concerns and focus areas, and be able to articulate the key messages to the Asset Leadership Teams to support compliance in a timely manner.
- Build and maintain strong relationships with regulators; identify escalation pathways and future engagement strategies as a strategic investment in long term compliance and advocacy.
- Scan for emerging regulatory trends/focus areas; apply learnings across assets.
- Identify areas requiring additional research/compliance support; coordinate internal/ external studies/activity to inform advocacy positions and compliance plans.
- Coordinate internal stewardship discussions to facilitate appropriate oversight and cross-asset learnings and support stewardship of regulatory enforcement and regulatory commitments to closure.
- Assemble, engage, and coordinate cross functional issue management teams to develop and implement compliance strategies/plans and support compliance efforts.
- Support business representation in industry groups or activities.
- Provide trusted regulatory advice; to advise on implementation of appropriate regulatory practices, impact avoidance and mitigation measures for assets.
- Lead development and alignment of tools, guidance, and training for regulatory processes/programs.
Requirements
- A relevant degree or equivalent experience
- 1–5 years in compliance, regulatory, QA, or governance support
- Strong documentation and deadline management
- Industry exposure to regulated environments
Benefits
- Meaningful and interesting projects
- Flexible working arrangements
- Commitment to Diversity and Inclusion
- Competitive remuneration package
- Flexible benefits
- Commitment to continued professional development
- Global connections
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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