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Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory CMC Sciences Project Management to oversee complex regulatory projects, particularly focused on manufacturing site transfers and alternate API sourcing. The ideal candidate will have extensive experience in regulatory affairs, project management, and strong communication skills, contributing to Viatris's mission to improve global healthcare access.
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Job Summary
The role serves as a regulatory expert managing global, large-scale manufacturing site transfers and alternate API sourcing activities.
Candidates must provide project management support for complex network optimization projects while coordinating priorities across multiple stakeholders.
Viatris offers competitive salaries, bonus schemes, health insurance, pension plans, and an inclusive environment focused on diversity and sustainability.
Matching Summary
Match Score: 75
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Alphapharm Pty Ltd T/A Viatris is seeking a Director of Regulatory CMC Sciences Project Management to oversee complex regulatory projects, particularly focused on manufacturing site transfers and alternate API sourcing. The ideal candidate will have extensive experience in regulatory affairs, project management, and strong communication skills, contributing to Viatris's mission to improve global healthcare access.
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Salary
Competitive salary; Bonus scheme available; Health insurance and pension included
Skills & Requirements
Must-have
Hands-on CMC authoring experience
Post-approval variation management
Site transfer regulatory strategy
Alternate API sourcing expertise
Matrixed team leadership
Nice-to-have
Strategic thinking in global markets
Mentoring and sharing experience
Advanced communication skills
Dashboard development capabilities
Collaborative culture fit
Key Requirements
Mandatory hands-on CMC authoring experience
Proven capability in managing complex Regulatory projects
Extensive knowledge of post-approval variations
Experience with cGMP assessment
Advanced understanding of global regulatory requirements