Regulatory Manager
Core
Provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of quality regulatory submissions in compliance with applicable regulations.
Role type
Senior Regulatory Manager (Clinical Development)
Builds
Regulatory submissions (CTA/IND, annual reports, marketing applications) and strategic regulatory input for drug development programs.
Domain
Pharmaceutical / Biotechnology / Clinical Trials
Required skills
Regulatory affairs experience, knowledge of drug development process, regional regulatory expertise (EU/US), clinical trial methodology, ICH GCP guidance, project management, team leadership
Preferred skills
Graduate/postgraduate degree, financial management understanding
Technologies
MS Office / Office 365
Responsibilities
Compile and review applications to Regulatory Authorities, develop submission documents, serve as representative at project and business development meetings, oversee Regulatory Affairs Specialists, maintain project plans and trackers, provide training on ICH GCP, assist in regulatory strategy development.
Seniority
Senior, hands-on IC with team leadership