Manager managing regulatory registration requirements for health authority submissions across multiple markets. Collaborating with cross-functional teams to ensure compliance with global standards and drive improvements.
Responsibilities
Manage end-to-end preparation of regulatory registration requirements for health authority submissions
Coordinate with cross-functional teams to execute regulatory submission strategies
Mentor and develop team members
Ensure compliance with global regulatory standards
Drive continuous improvement and system innovation
Requirements
Bachelor’s degree or higher in pharmaceutical, biological or healthcare science
Significant relevant regulatory/submission experience with local health authorities
Strong understanding of international regulations
In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing
Strong awareness of GMP principles
Ability to interpret regulations and gain consensus on a way forward
Strong written and verbal communication skills
Demonstrated agility in adapting to rapidly changing priorities and timelines
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