Senior RA Consultant role at Parexel. Provide expert local regulatory support for post-auth lifecycle (variations, renewals, PSURs) in Australia & New Zealand. 5+ yrs local RA exp, deep HA knowledge & project leadership req. #RegulatoryAffairs #ANZ #PharmaConsulting #Remote #Parexel #LifecycleManagement
Lead Regulatory Strategy & Lifecycle Management for the ANZ Market
This senior consulting role is for an expert regulatory professional with deep, hands-on experience in the Australian and New Zealand pharmaceutical markets. You will act as a strategic partner and project lead, providing end-to-end regulatory support for post-authorization lifecycle maintenance. Your expertise will ensure clients' marketing authorizations remain compliant, and you will manage critical Health Authority (HA) interactions, submissions, and local regulatory processes.
Your Mission: Strategic Regulatory Leadership & Project Delivery
You will blend deep technical regulatory knowledge with consulting and project management excellence to deliver high-value services to clients.
Key Regulatory Accountabilities (ANZ Focus):
- Lifecycle Management Expertise: Apply strong knowledge of post-authorization procedures—variations, renewals, PSURs, CMC changes—to maintain multiple product licenses in ANZ.
- Local Submission Leadership: Prepare, organize, and coordinate Module 1 and local documentation to meet TGA (Australia) and Medsafe (New Zealand) submission requirements. Maintain up-to-date national systems per local legislation.
- Health Authority & Stakeholder Management: Comprehensively understand local HA processes. Manage HA interactions, question responses, and support inspections. Coordinate impact assessments with non-regulatory stakeholders (Medical, Marketing, Supply).
- Regulatory Intelligence: Stay updated on ANZ regulatory requirements and guidelines. Proactively communicate changes to global teams and share insights to ensure compliance.
Project Execution & Leadership:
- Project Lead Responsibilities: Serve as a Project Lead for small projects or Work Stream Lead for larger engagements. Responsible for planning, setup, financials (forecasting, invoicing), risk management, and ensuring quality/timeliness of deliverables.
- Client Relationship Management: Function as the main client contact, ensuring accurate reporting and that the project team meets client expectations. Identify new business opportunities through scope changes.
- Team Guidance & Delivery: Work effectively within and lead teams, prioritize work, and ensure project outcomes align with objectives. Produce quality work that meets client and Parexel standards.
Consulting & Business Development:
- Deliver consulting services within your regulatory expertise, identifying issues and proposing solutions.
- Interact professionally at all levels within client organizations and Parexel.
- Communicate potential new business leads and may participate in scoping calls/proposal preparation.
Who You Are: The ANZ Regulatory Expert & Consultant
You are a client-focused, results-oriented professional who combines deep local regulatory knowledge with strong project leadership skills.
Knowledge and Experience:
- Minimum of 5+ years of experience in a pharmaceutical industry regulatory affairs role.
- Must have extensive, direct experience supporting Australia and New Zealand markets. Comprehensive understanding of TGA and Medsafe processes is essential.
- Proven experience with post-authorization lifecycle activities (variations, renewals, PSURs, labelling updates).
- Project management experience is highly advantageous.
Education & Skills:
- Minimum Bachelor’s Degree in a Scientific or Technical Discipline (Life Sciences, Pharmacy, Chemistry, etc.).
- Client-focused approach with strong results orientation.
- Excellent teamwork, collaboration, and communication skills (written and verbal).
- Critical thinking and problem-solving abilities.
- Proficiency in English is required.
#LI-REMOTE (Must be located in/authorized to work in Australia or New Zealand).
Ready to Be the Trusted Regulatory Advisor for the ANZ Region?
If you are a senior regulatory affairs specialist with in-depth ANZ market expertise and a desire to lead projects and advise global clients, we encourage you to apply.
This remote role offers the opportunity to shape regulatory strategy and ensure market access for critical therapies in Australia and New Zealand.
Apply now to join Parexel's Global Regulatory Affairs Consulting team.
