Responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products in accordance with global regulations, with a focus on small molecule respiratory/inhalation product development
Job Summary
Responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products in accordance with global regulations, with a focus on small molecule respiratory/inhalation product development.
Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products.
Partners with Quality colleagues strategically prepare for and lead pre-approval and regulatory inspections, ensuring launch readiness and regulatory success.
Matching Summary
Responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products in accordance with global regulations, with a focus on small molecule respiratory/inhalation product development.
Salary
$190,800.00 - $300,300.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days
Skills & Requirements
Must-have
Global regulatory CMC strategy
Small molecule respiratory/inhalation
Lead oversight of multiple programs
Develop and implement CMC regulatory strategies
Regulatory intelligence and risk assessment
Nice-to-have
Continuous improvement culture
Talent development and succession planning
Innovative and scientifically sound approaches
Collaborative relationships with stakeholders
Key Requirements
Master's degree in chemistry, Pharmacy, or related discipline
Minimum 15 years pharmaceutical industry experience
Minimum 5 years working in Regulatory CMC
Minimum 3 years managing people
Regulatory CMC experience with complex drug-device combination products/inhalation products