Global CMC Dossier Strategy Leader

AbbVie Inc.; North Chicago (IL); On-site; USD 142,000 - 269,000; Full time

Job summary

AbbVie Inc. is seeking an Associate Director for CMC Dossier Strategy & Leadership to oversee global regulatory dossier preparation for biologics, coordinating internal and external experts to ensure high-quality CMC submissions.

The role aligns with the clinical development strategy and regulatory requirements, driving first-pass approvals and governing later-stage programs. The incumbent leads cross-functional teams, develops templates and processes, mentors staff, and interfaces with CMC

Qualifications

• Bachelor's degree in a life sciences field; 8–10 years CMC experience required.
• Master's degree in life sciences preferred with 6–8 years CMC experience.
• PhD in a related field highly preferred with 4–6 years CMC experience.

Responsibilities

• Author and coordinate submission documentation for all phases of clinical development of biologics, with emphasis on later phase programs and marketing applications.
• Lead global cross-functional CMC team to complete regulatory submission documents; ensure awareness of global regulatory requirements.
• Demonstrate excellent interpersonal and negotiating skills with external partners and internal stakeholders.
• Manage completion of CMC regulatory submission documentation for multiple projects of moderate complexity using a matrix management approach.
• Interface with the CMC Regulatory group; develop processes and templates for submission documents.
• Partner with CMC Regulatory to identify submission-related risks and mitigation strategies.
• Develop organizational memory of regulatory issues; review guidance documents to maintain expertise.
• Coordinate document authoring and reviews with groups outside DPD such as Process R&D Operations S&T, preclinical safety, PK, and QA.
• Represent the CMC team in communications to DSL management and drive cross-functional initiatives to streamline submission processes.
• Mentor/supervise a team of dossier authors and evaluate performance.

Skills

CMC experience

Regulatory writing

Cross-functional leadership

Biologics knowledge

Education

Bachelor's degree (life sciences)

Master's degree (life sciences)

PhD (life sciences)

Job description

AbbVie Inc. is seeking an Associate Director for CMC Dossier Strategy & Leadership to oversee global regulatory dossier preparation for biologics, coordinating internal and external experts to ensure high-quality CMC submissions.

The role aligns with the clinical development strategy and regulatory requirements, driving first-pass approvals and governing later-stage programs. The incumbent leads cross-functional teams, develops templates and processes, mentors staff, and interfaces with CMC