Regulatory Operation Manager (including Writing Role)

Job Summary

To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards.

To focus mainly on filing & submission of CTNs / MAAs / variations

Key Activities

Author the regulatory documents (With limited supervision):

• Author regulatory submission documents, as assigned, mainly including, Briefing Documents, Responses to Questions, CSS of Protocol, China special addendum for eCTD Module 2 Clinical Summary Documents, and other regulatory documents
• Conduct the formal review and approval of authored documents, following applicable standard operating procedures
• Serve as writing lead on product teams (e.g., China Product Team, China Regulatory Team)
• May participate in training and mentoring of junior medical writers
• May participate in departmental and cross-departmental initiatives, as appropriate
• Generate document timelines, with team input
• Keep abreast of relevant professional information and technology.

Filing and submission:

• Lead submission in partnership with TA team
• Coordinate and follow the dossier package preparation with CMC team and cross-functions
• Analyze the gaps and needs for China RA in early phase submission
• Arrange dossier package printing and binding to ensure the submission on time
• Control the package filing strategy to facilitate simultaneous filing
• Be responsible for managing the archiving dossiers, certificates and approval letters

Knowledge and Skills

• Excellent written/oral communication skills and attention to detail in both English and Chinese
• Proficiency with word processing and other Microsoft Office Programs
• Significant knowledge of scientific/technical writing and editing, and of overall clinical development process for new compounds
• Ability to effectively demonstrate leadership in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment
• Ability to understand and follow complex standard operating procedures (SOP’s), guidance documents, and work instructions
• Proficient time and project management skills
• Self-starter with a drive and perseverance to achieve results
• Local regulatory regulation knowledge
• Good team player