Senior Regulatory Affairs Professional
Core
Senior Regulatory Affairs Specialist ensuring compliance with Australian regulatory requirements for pharmaceutical products.
Role type
Senior Regulatory Affairs Specialist
Builds
Regulatory dossiers, drug master files, and licence renewals for pharmaceutical products
Domain
Pharmaceutical industry / Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory planning, submission preparations, regulatory body discussions, project planning, eCTD proficiency, workflow management, compliance strategy development
Preferred skills
eCTD proficiency
Responsibilities
Manage and lead product compliance with internal and external Australian regulatory requirements; Develop regulatory strategies to support business growth; Prepare documentation for regulatory dossiers, drug master files, and licence renewals; Track progress and due dates for legal and regulatory matters
Seniority
Senior, hands-on IC
