Teams at AbbVie

Lead CMC regulatory strategy and manage regulatory submissions (INDs/CTAs, marketing applications, amendments) for biologics. Prepare agency meeting strategies, oversee change control and manufacturing requests, respond to regulatory information, and represent CMC in cross-functional teams to enable first-pass approvals.

Lead global regulatory strategy and product teams to secure and maintain market approvals across drug development and lifecycle. Develop regulatory dossiers, risk mitigation, labeling strategy, and alignment with senior management; interface with cross-functional stakeholders and regulatory agencies; mentor team members and drive regulatory policy and initiatives.

Designs and executes novel experiments, develops and optimizes methods, supports late-stage and commercial biologics manufacturing, technology transfer, process validation, scale-up, investigations and troubleshooting, mentors others, authors scientific/regulatory documents, and ensures GxP and safety compliance.