Regulatory Operation Manager (including Writing Role)
Regulatory Operation Manager (including Writing Role)
China - Beijing Apply Now
JOB ID: R-184417
LOCATION:
China - Beijing
WORK LOCATION TYPE:
On Site
DATE POSTED: Mar. 20, 2024
CATEGORY: Regulatory
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