Sr. Director, Regulatory Affairs
Core
Lead regulatory strategy and compliance for a biopharmaceutical company developing novel treatments using advanced microscopy technology.
Role type
Senior Director, Regulatory Affairs
Builds
Biotechnological innovations and novel drug treatments
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
FDA and international regulatory knowledge, submission management, cross-functional collaboration, risk assessment, quality assurance supervision, strategic planning
Preferred skills
None stated
Technologies
None stated
Responsibilities
Develop and execute regulatory strategies for product development and commercialization; oversee preparation and submission of regulatory documents (IND, NDA, MAA); collaborate with R&D, QA, and Clinical Development teams; supervise regulatory aspects of quality systems (GCP, GLP); identify and mitigate regulatory risks
Seniority
Senior, hands-on IC with leadership responsibilities
