Intern- Regulatory Affairs- CMC
Core
Execute and manage APAC region regulatory submissions for new product registrations and life-cycle changes to ensure product compliance and availability.
Role type
Intern Regulatory Affairs (CMC)
Builds
Regulatory submission packages for pharmaceutical products
Domain
Pharmaceutical industry / Regulatory Science
Deliverable
client delivery
Required skills
Regulatory CMC, Regulatory Documents, eCTD, Compliance Investigations, Policy Implementation, Analytical Problem Solving, Detail-Oriented
Preferred skills
Fluency in an APAC region language
Technologies
Electronic Common Technical Document (eCTD)
Responsibilities
Generate regulatory strategies, Review submission packages, Liaise with colleagues globally, Work on operational excellence projects, Develop best practices for regulatory science, Learn and apply regulatory policy and advocacy
Seniority
Intern, student placement
