Role responsibilities
The Senior Manager, Regulatory Submissions is responsible for managing regulatory submissions to Health Authorities and ensuring compliance with ICH specifications. This includes maintaining regulatory information, mentoring team members, and coordinating with various functional leads.
Requirements
Candidates must have a bachelor's degree in a relevant field and a minimum of experience in a regulatory affairs environment. Strong technical knowledge in publishing systems and experience with global regulatory submission content is also required.
Key skills
Regulatory Affairs, Document Management, Electronic Publishing, eCTD, Global Health Authorities, Drug Development, SPL, Advertising Submissions, Promotional Submissions, Device Submissions, Combination Products, MS Word, Adobe, Organizational Skills, Communication Skills, Writing Skills
Keywords
Regulatory Affairs, Document Management Systems, Electronic Publishing, eCTD, Global Health Authorities, Drug Development, SPL, Advertising Submissions, Promotional Submissions, Device Submissions, Combination Products, MS Word, Adobe, Regulatory Submissions, Compliance, ICH Specifications