What are the responsibilities and job description for the (Associate) Manager, Regulatory Affairs position at CORXEL Pharmaceuticals?
#Exciting opportunity to join in global innovative drug development team, work with seasoned RA leader for US/EU/Japan registration for Phase II/III IND/NDA approvals! #
Responsibilities
· This role supports multiple global regulatory projects, ensuring compliance with all relevant regulatory requirements and guidelines
· Assist and help prepare and submit regulatory filings (e.g., IND, CTA/IMPD, annual reports/progress reports, briefing documents, etc.)
· Follow up on global regulatory initiatives in preparation and submission of global marketing authorization applications
· Work with global regulatory lead to create and maintain submission project plans, content plans, and responsibility matrices and timelines to ensure consistency and completeness to standards for all regulatory submissions
Manage regulatory infrastructure (document management system)
Qualifications
At least 3 years’ experience in Innovative drug global registration.