Associate Director, CMC Dossier Strategy and Leadership

Role Summary

Associate Director, CMC Dossier Strategy and Leadership. Hybrid role requiring presence in a designated AbbVie US office (North Chicago, Irvine, South San Francisco, Worcester MA, Waltham MA) three days per week. Leads global regulatory dossier preparation activities for novel biologics by coordinating cross-functional teams to ensure high-quality CMC submission documents aligned with global regulatory requirements and development strategy.

Responsibilities

• Author and coordinate submission documentation for all phases of clinical development of biologics, with emphasis on later phase programs and marketing applications, often under significant time pressure. Drive team resolution and author responses to questions from regulatory authorities.
• Lead the global cross-functional CMC Team in completion of global regulatory submission documents; maintain awareness of global regulatory requirements and implement changes in local practices and procedures.
• Develop strong relationships with external partners and internal stakeholders; demonstrate negotiating, influencing, and leadership skills.
• Manage completion of CMC regulatory submission documentation for multiple projects of moderate complexity using a matrix management approach.
• Interface with the CMC Regulatory group as the primary Drug Product Development representative; develop standard processes and lead project teams in planning, preparation, review, and approval of CMC submission documentation; develop and maintain submission document templates.
• Partner with CMC Regulatory to identify submission-related risks and develop mitigation strategies.
• Develop organizational memory of regulatory issues; review regulatory guidance to maintain expertise; coordinate document authoring with groups outside of DPD (e.g., Process R&D Operations S&T, preclinical safety, PK, QA).
• Interface with CMC Regulatory to ensure consistency across projects; represent the CMC team in communications to DPD management.
• Develop and maintain tools and templates to facilitate submission processes; lead cross-functional initiatives to streamline dossier preparation.
• Facilitate the establishment of high-performing teams; may mentor/supervise a team of dossier authors and evaluate performance.

Qualifications

• Bachelors Degree with at least 8‚Äì10 years of CMC experience required; Masters Degree with at least 6‚Äì8 years of CMC experience preferred; PhD with at least 4‚Äì6 years of CMC experience highly preferred.
• Interdisciplinary experience required; biologics experience strongly preferred.
• Excellent scientific writing skills including contributions to INDs and/or marketing applications; knowledge of regulatory requirements.
• Strong written and verbal communication skills with ability to summarize and communicate findings timely and efficiently.