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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%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.