Regulatory Affairs Intern
Core
Support the Regulatory Affairs Team in New Product Registration, product Registration Life-Cycle Management, and strategic planning for new launches and post-approval variations.
Role type
Regulatory Affairs Intern
Builds
Regulatory submissions and lifecycle management for pharmaceutical products
Domain
Pharmaceuticals / Regulatory Compliance
Deliverable
client delivery
Required skills
Adverse Event Reporting, Audits Compliance, Data Quality Assurance, Document Control Systems, Electronic Common Technical Document (eCTD), Pharmacovigilance, Policy Implementation, Product Registrations, Records Retention Management, Regulatory Applications, Regulatory Communications, Regulatory Compliance Audits, Regulatory Strategy Development, Stakeholder Engagement, Strategic Planning
Preferred skills
None stated
Technologies
Document Control Systems, Electronic Common Technical Document (eCTD)
Responsibilities
Handle New Product Registration and product Registration Life-Cycle Management; Provide support to cross-functional teams such as Tender and In-Market Quality support; Handle AE reporting and data verification; Attend Drug Office and Medical Device seminars; Work with stakeholders such as DOH officers, CPO, and Legal Advisors.
Seniority
Intern/Co-op (Fixed Term)
