Director, Submission Operations Management

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This position resides in the Global Regulatory Operations Strategy & Innovation and will interact at all levels, including BeOne’s Senior Management.  This role will manage the submission teams for North America, Latin America, EEA, Middle East and Africa submission dossiers for regulatory Health Authority review and approval. This position will have interactions with supporting functional areas such as CMC, Reg Strategy, Clinical/Non-Clinical, Quality/Manufacturing, GTS, Pharmacovigilance and Regulatory Compliance.  This position will also play a key role in getting authoring teams within BeOne to adopt authoring in Veeva RIM and help to enable efficiencies therein.  

Provide leadership to Regulatory Submissions Operations Management teams (e.g. Regional Submission Operations, Submission Dossier Management, Publishing, and Technical Editing). This includes providing direction to establish submission timelines, and deliverables ensuring internal global processes for electronic/paper publishing meets requirements and standards established by global Health Authorities. Ensure electronic archiving of submissions and related correspondence is accessible for internal staff and for internal/external audit and inspections.  This leadership role will also include the expectation of negotiating with RA teams to insure submissions are requested and documents supplied in a reasonable timeframe to enable Submission Publishers & Submission Dossier Managers work/life balance.

Essential Functions of the job:

Accountable and responsible for building and maintaining relationships within Regulatory Affairs and functional organizations including partnering with Quality (GxP Systems) and IT business partners to ensure effective communication and efficient management of regulatory technology and systems, as well as processes, as outlined below:

• Lead or Monitor ongoing projects within the GROSI team and report status updates to management.
• Apply strong project management skills to guide Submission Dossier Managers and collaborate with Regulatory Project Management.
• Provide guidance on submission standards and quality processes, including checklists, authoring standards, timelines, and tools.
• Serve as APAC lead and SME for developing global electronic/paper submission processes and quality control procedures.
• Align with RIM resources on data remediation, quality, and standards.
• Outline and communicate to management resource requirements to support system enhancements, user training and routine global system support for users.
• Collaborate with internal stakeholders/customers to ensure alignment in strategy, communication, and delivery.
• Monitor and support teams in response to new or updated health authority guidance.
• Liaise with Health Authorities to negotiate electronic submission requirements and deliverables.
• Collaborate with the Reg Technology function on system needs, training, and upgrades.
• Perform impact analysis and prepare the organization to meet new global regulatory requirements.
• Lead and participate in business process and systems configuration decisions.
• Manage business processes, operations, and updates for all Regulatory systems to support internal customer needs.
• Support GROSI in planning, configuring, validating, and implementing systems for successful production deployment and post-production support.
• Act as the primary conduit for stakeholders to address Regulatory Operations system issues, requests, and expectations for assigned regions while identifying global process alignment opportunities.
• Communicate and align with internal stakeholders/customers to ensure strategy and delivery are consistent.
• Ensure compliance with internal SOPs, GxP standards, and audit requirements.
• Provide resource/headcount planning and insights into submission schedules to anticipate resourcing needs.
• Engage with industry experts and regulatory agencies on evolving guidance and technologies impacting submissions.
• Manage external vendors, ensuring clarity on expectations, timelines, and work quality, as needed.
• Lead and participate in business process and systems configuration workshops.
• Provide support to QA/Compliance during system and business process audits.
• Provide input to Regulatory Technology/RIM leads responsible for planning and building systems (spanning configuration and validation) to ensure successful production implementation, smooth transition for post-production support and system enhancements.

Technology Knowledge Needed:

·     Expert in Microsoft Office Suite (Word, Excel, OneNote, Teams) and Adobe Acrobat

·     eCTD Publishing/Viewing software experience (e.g. InSight, Veeva Publishing).  XML knowledge a bonus.

·     eCTD Validator software experience (e.g. Lorenz, EURS is Yours)

·     Regulatory Submission Publishing experience required

·     Document management systems (e.g. Documentum, Veeva Vault)

·     Regulatory information management systems (e.g. InSight, Veeva Vault)

·     Collaboration Tools (e.g. SharePoint, Smartsheet)

·     Off-the-shelf and plug-in software (StartingPoint Templates, DXC Toolbox)

Education/Experience Required:

Minimum of 10 years of Regulatory Operations experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 6 years’ experience in a regulatory operations leadership role. Bachelor’s degree required. Master’s degree in Reg Affairs a plus.

Other Qualifications:

Travel: <20%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.