AD / Director - Regulatory Affairs - FSP Team
Core
Provide strategic and operational regulatory leadership for late-stage global development programs from clinical development through marketing authorization and lifecycle management.
Role type
Associate Director / Director, Regulatory Affairs
Builds
Global regulatory strategies, submission dossiers, and responses to health authority assessments
Domain
Pharmaceutical/Biotechnology, European drug development and registration
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy execution, dossier preparation, health authority interaction, CTIS management, risk identification, labeling and post-authorization activities, cross-functional coordination, scientific judgment, project leadership
Preferred skills
Advanced degree in life sciences/pharmacy/medicine, experience in innovative biotechnology environments
Technologies
CTIS, ICH guidelines, GCP
Responsibilities
Develop and execute regulatory strategy for assigned development programs; Lead regulatory planning and execution including pre-submission activities and submission readiness; Coordinate cross-functional development and review of regulatory submissions; Lead preparation of responses to assessment questions; Develop regulatory strategies and briefing packages for interactions with authorities; Provide regulatory leadership for clinical trial activities conducted through CTIS; Identify and communicate emerging regulatory risks and opportunities; Contribute to labeling, product information, and Risk Management Plans; Represent Regulatory Affairs on development teams and governance forums; Build strong partnerships across functions and external stakeholders
Seniority
Director level, hands-on IC with strategic scope