Director, Global CMC Regulatory & Submissions

BioSpace; Philadelphia (Philadelphia County); Vor Ort; USD 148.500 - 217.800; Vollzeit

Benefits dieser Stelle

401(k) and pension

Comprehensive health benefits

Vacation

Employee assistance program

Zusammenfassung

A leading pharmaceutical company is seeking a qualified Director, CMC Regulatory to lead global regulatory CMC strategies for diagnostic radiopharmaceutical products. You will be responsible for generating country-specific regulatory strategies and leading submissions globally. The ideal candidate will have over 10 years in drug development, including direct CMC regulatory experience. A BS Degree in a related field is required, with an advanced degree preferred. Competitive compensation and benefits are offered, with an expected salary range of $148,500 to $217,800.

Qualifikationen

• Minimum of 10 years in pharmaceutical drug development and/or pharmaceutical manufacturing.
• At least five years of direct CMC regulatory experience.

Aufgaben

• Generate and execute country-specific CMC regulatory strategies.
• Lead global CMC regulatory submissions including authoring and finalization.
• Respond to regulatory agency questions globally.
• Review change controls and technical documents from a CMC regulatory perspective.

Kenntnisse

CMC regulatory experience

Technical writing skills

Leadership skills

Communication skills

Ausbildung

BS Degree in science, engineering, or a related field

Advanced degree

Tools

MS Office

Jobbeschreibung

A leading pharmaceutical company is seeking a qualified Director, CMC Regulatory to lead global regulatory CMC strategies for diagnostic radiopharmaceutical products. You will be responsible for generating country-specific regulatory strategies and leading submissions globally. The ideal candidate will have over 10 years in drug development, including direct CMC regulatory experience. A BS Degree in a related field is required, with an advanced degree preferred. Competitive compensation and benefits are offered, with an expected salary range of $148,500 to $217,800.