stage 6 mois affaires réglementaires cmc
Core
Prepare international regulatory submissions for variations within a major industrial project for biologics.
Role type
Regulatory Affairs Intern (CMC)
Builds
Regulatory dossiers for biologics products
Domain
Biopharmaceuticals / Regulatory Affairs
Required skills
CTD knowledge, Module 3 knowledge, European variation guidelines knowledge, attention to detail, analytical thinking
Preferred skills
Teamwork
Technologies
CTD, Module 3, European variation guidelines
Responsibilities
Contribute to dossier preparation in liaison with CMC writers, Participate in the international submission process, Support local teams' document requests, Participate in regulatory planning for the industrial project, Support the global team's regulatory strategy and help prepare responses to European health authorities
Seniority
Intern
Sourced via workday · Listed on CareerPlan, which tracks 902,000+ jobs from 20+ sources.