Director of RA CMC Knowledge Management & Strategy
Core
Develop and advocate strategic positions for CMC regulatory issues with cross-functional stakeholders to accelerate AbbVie's portfolio.
Role type
Director of Regulatory Affairs CMC Knowledge Management & Strategy
Builds
Robust product strategies integrating CMC regulatory policy and expectations
Domain
Biopharmaceuticals / Regulatory Affairs / CMC
Deliverable
client delivery
Required skills
Strategic thinking, influencing, negotiation, advocacy, global CMC regulatory knowledge, enterprise leadership, relationship building with regulatory authorities, industry forum presence, business acumen, complex matrix environment navigation, global regulatory strategy development
Preferred skills
Advanced degree in scientific/health/business discipline, regulatory certifications, FDA or major global health authority experience, CMC trade association experience
Technologies
Regulatory databases, Reg Requirements Portal
Responsibilities
Deliver strategic CMC regulatory insights and guidance to cross-functional stakeholders, lead data-driven decision-making by leveraging regulatory databases, oversee development of regulatory CMC process documents and templates, influence cross-functional stakeholders through position papers and policies, collaborate with regional SMEs to monitor emerging regulatory CMC trends, advise on critical regulatory submissions, advocate with regulatory agencies and industry groups, champion AI implementation for CMC regulatory applications, lead benchmarking and contribute to industry publications
Seniority
Director, enterprise leadership