Manager, Submission Management

focuses on operational delivery and does not own regulatory strategy decisions.
In addition, this position may provide operational support for document formatting, report-level publishing, submission publishing, and regulatory data disclosure activities (e.g., CDE Clinical Trial Registration), as business needs require.

Submission Planning and Execution
Lead submission execution activities for assigned programs or regions
Develop and maintain detailed submission plans in partnership with Regulatory Project Management
Coordinate submission deliverables across Clinical, CMC, Non‑Clinical, Safety, Regulatory, and other functions
Support execution of original submissions, amendments, responses, and lifecycle activities
Ensure submission readiness criteria, dependencies, and timelines are clearly communicated and tracked
Support submission readiness reviews and final go or no go activities

Quality and Compliance
Ensure submission components meet global and regional Health Authority technical and formatting requirements, including CTD and eCTD standards
Apply standard submission management checklists, tools, and quality controls
Identify submission risks early and work proactively with stakeholders to resolve issues
Maintain accurate, inspection‑ready submission records and documentation

Collaboration and Partnership
Partner closely with Regulatory Project Managers to drive submission timeline adherence
Work with Global and Regional Regulatory Strategy to translate agreed strategies into executable deliverables
Collaborate with Publishing to ensure clear handoffs, publishing readiness, and submission delivery
Communicate submission risks, constraints, and dependencies clearly and early
Serve as a reliable execution partner during critical submission milestones

Tools, Systems, and Process Support
Support effective use of submission and document management systems, including BRIM and related Regulatory Operations platforms
Contribute to the development and maintenance of submission management tools, templates, and job aids
Support implementation of new or updated Health Authority guidance impacting submission operations
Participate in continuous improvement initiatives to enhance submission efficiency and quality.

People Leadership and Development
Support consistent ways of working and knowledge sharing across submission teams
Contribute to team workload planning and visibility into upcoming submission demands

What Best in Class Looks Like in This Role
• Submissions are delivered on time and right the first time
• Submission risks are anticipated and addressed proactively
• Stakeholders experience clear ownership and predictable execution
• Standards, tools, and expectations are consistently applied
• Quality and execution discipline improve with experience level

Why This Role Matters
Regulatory submissions are a direct reflection of BeOne’s science, rigor, and credibility with health authorities. This role ensures submissions are executed with clarity, precision, and discipline, enabling timely approvals and delivering therapies to patients safely and efficiently.

Education Required: 
Bachelor’s degree in Science, Pharmacy, Life Sciences, or a related discipline (required).
Advanced degree is preferred

Other Qualifications Experience:
Manager: typically 6 or more years of experience in Regulatory Operations, Submission Management, Regulatory Submissions, or Publishing.
Experience supporting global or regional regulatory submissions, including marketing applications and lifecycle activities.
Working knowledge of CTD and eCTD structures and Health Authority submission requirements, including FDA, EMA, NMPA and ICH guidance.
Proven ability to coordinate complex submission activities in a cross‑functional, matrixed environment.
Experience partnering with Regulatory Project Management, Regulatory Affairs, and cross‑functional authoring teams.
Hands‑on experience with regulatory document and submission management systems.
Strong attention to detail with a quality‑focused mindset.
Clear written and verbal communication skills.
Experience working with vendors supporting submission publishing or dossier management is preferred.
Key Attributes
Organized, dependable, and execution focused
Comfortable managing multiple priorities under tight timelines
Proactive in identifying risks and proposing solutions
Collaborative and professional in cross‑functional environments
Travel:  
Occasional international and domestic travel may be required to support global project teams, attend regulatory meetings, or participate in industry conferences.
Travel requirements will vary based on project needs and organizational priorities.

Candidates from Associate Manager to Senior Manager may be considered, depending on experience and qualifications.

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This position works closely with Regulatory Project Management, Global and Regional Regulatory Strategy, Publishing, Regulatory CMC, and cross-functional authoring teams to translate agreed regulatory strategies into executable submission plans.