Senior Manager, Regulatory and PV Delivery
Ergomed · Melbourne
Job description
About the role
The Senior Manager, Regulatory and PV Delivery will act as the primary liaison between Ergomed Group and clients across multiple projects, providing strategic regulatory guidance and supporting business development activities.
Key responsibilities
- Lead high‑complexity regulatory projects, ensuring timely execution and compliance with procedures, trackers and templates.
- Provide expert advice on complex regulatory queries and changes in local regulations.
- Support business development by contributing to proposals, budgets and regulatory costing.
- Mentor and coach junior staff; may include line‑management responsibilities.
- Ensure audit readiness and represent the department during audits/inspections.
Required profile
- Minimum 5 years in the pharmaceutical or CRO industry (or regulatory body) with at least 3 years in a leading/project‑management role.
- Proven ability to manage global projects successfully.
- Strong knowledge of ICH GCP and/or GVP and relevant local legislation.
Required skills
- Expert knowledge of ICH GCP and GVP.
- Hands‑on experience with post‑marketing regulatory activities and lifecycle management.
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Published 1 day ago
Expires 1 month from now
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Ergomed
Melbourne