Senior Director - Regulatory Affairs CMC
November 16
Description
• Responsible for global management and leadership of regulatory activities relating to CMC. • Define and execute global regulatory affairs CMC strategies for product development and compliance. • Collaborate with regulatory stakeholders to ensure accurate submission of regulatory documentation. • Lead cross-functional submission teams for global regulatory documents within timelines. • Establish relationships with regulatory agencies to ensure timely approval of applications. • Remain knowledgeable about current regulations and notify personnel of changes.
Requirements
• Bachelor’s Degree in a scientific and/or Life Sciences discipline. Advanced degree preferred. • Minimum of 12 years in drug/biologics development in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 7 years of experience in a regulatory leadership role. • Demonstrated track record of successful approvals and extensive regulatory agency liaison experience is essential. • Strong expertise and knowledge of the drug development process, Global submissions (eg NDA/MAA/NDS) and launch requirements is required. • Strong understanding of US and European Union laws and procedures relating to drug market authorizations. • Leadership experience managing a team of Regulatory CMC professionals.
Benefits
• Premium health, financial, work-life and well-being offerings for eligible employees and dependents. • Wellness and employee support programs. • Life insurance. • Disability. • Retirement plans with employer match and generous paid time off.
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