CMC Dossier Strategy Lead – Global Biologics

BioSpace; North Chicago (IL); Vor Ort; USD 150.000 - 210.000; Vollzeit

Zusammenfassung

AbbVie is seeking a senior professional to lead global regulatory dossier preparation for biologics, coordinating cross-functional experts to ensure high-quality CMC submission documents in line with global requirements.

You will influence submission strategies, manage complex projects, and act as a DSL representative interfacing with the CMC Regulatory group, while mentoring junior team members as needed.

Qualifikationen

• Bachelor’s degree with 8–10 years of CMC experience.
• Master’s degree with 6–8 years of CMC experience preferred.
• PhD degree with 4–6 years of CMC experience highly preferred.

Aufgaben

• Author and coordinate submission documentation for all phases of clinical development of biologics, with emphasis on later phase programs and marketing applications.
• Drive team resolution and respond to questions from regulatory authorities.
• Lead global cross-functional CMC team in completion of global regulatory submission documents.
• Maintain awareness of global regulatory requirements for pharmaceutical development.

Jobbeschreibung

AbbVie is seeking a senior professional to lead global regulatory dossier preparation for biologics, coordinating cross-functional experts to ensure high-quality CMC submission documents in line with global requirements.

You will influence submission strategies, manage complex projects, and act as a DSL representative interfacing with the CMC Regulatory group, while mentoring junior team members as needed.