Assoc Director, Regulatory Affairs
Core
Lead regulatory submissions and strategy for investigational and commercial products across assigned territories, ensuring compliance with ICH and regional requirements.
Role type
Senior Associate Director, Regulatory Affairs
Builds
Regulatory submissions (INDs, CTAs, NDAs, MAAs), safety reports, amendments, supplements, license renewals, and Company Core Data Sheets (CCDS).
Domain
Life Sciences / Pharma / Regulatory Affairs
Required skills
Regulatory strategy development, complex negotiation with authorities, team leadership, process improvement, stakeholder management, technical writing, compliance management, cross-functional collaboration.
Preferred skills
People management experience, scientific degree, experience on project teams.
Technologies
Regulatory submission systems, safety reporting tools.
Responsibilities
Prepare and oversee technically complex regulatory submissions; submit safety reports, amendments, supplements, and license renewals; prepare Company Core Data Sheets (CCDS); review draft Product Company Core Safety Information (CCSI); ensure product packaging and information updates; provide strategic regulatory advice; maintain knowledge of regulatory requirements; initiate process improvements; plan and schedule activities for self and direct reports; act as primary contact with Regulatory Authorities.
Seniority
Senior, hands-on IC with leadership responsibilities