Team Lead/Director Regulatory Affairs
Core
Develop regulatory strategy for novel cannabinoid-based pain treatment drugs from clinical development through market authorization in Europe and the USA.
Role type
Director/Team Lead Regulatory Affairs (Biopharma)
Builds
Regulatory dossiers, clinical trial applications, and market authorization submissions for Exilby and future products.
Domain
Biopharma / Chronic Pain Treatment / Regulatory Affairs
Required skills
Regulatory strategy development, cross-functional project management, stakeholder communication, regulatory document coordination, agency interaction, vendor management, team leadership, risk assessment
Preferred skills
Experience in consulting or pharma regulatory affairs, strategic steering experience, multilingual communication
Technologies
Regulatory submission platforms, clinical trial management systems, document management systems
Responsibilities
Develop overall regulatory strategy and derive development/submission plans; Advise project teams on regulatory requirements; Coordinate preparation and submission of clinical trial and marketing authorization applications; Ensure consistency and timely completion of regulatory documentation; Liaise with health authorities and prepare for advisory meetings; Monitor regulatory developments and adjust programs accordingly; Manage external regulatory service providers and CROs; Lead and develop the Regulatory Affairs team; Report on regulatory status, risks, and milestones to leadership.