Director, Global Submission Operations Management (Region Lead)

Emeryville, CA, United States

Position Summary:

This position will interact at all levels, including BeiGene’s Senior Management, responsible for creating, reviewing and/or approving submission dossiers for regulatory Health Authority review and approval. This position will have oversight for supporting functional areas such as Regulatory Affairs (CMC, Strategy, Project Management), Quality/Manufacturing, Clinical, and Non-Clinical in authoring content to internal submission standards ensuring Regulatory compliance.

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.

Essential Duties & Responsibilities:

Leadership role in the establishment and development of Submission Operations personnel (including Publishing team and Submission Dossier Managers) to enable active participation on project teams and/or submission planning meetings to communicate and drive adherence to timelines, and deliverable requirements.

Contribute to building a high performing team within the Regulatory Operations organization to effectively utilize talent for optimal organization effectiveness.

Responsible for functional resource/headcount planning. Has insight into planned submission schedule and proactively advises management of resource implications.

Knowledge of ongoing projects within the Regulatory Submission Operations team; sets expectations as appropriate and provides project status reports to management.

Strong project management skills to support guidance and development of Submission Dossier Managers with strong collaboration with the Regulatory Project Management function.

Provide direction and recommendations on submission standards and quality processes, including checklists, internal authoring standards, publishing timelines, and supporting tools.

Serve as Subject Matter Expert (SME) for leading the development of global processes to support electronic/paper submission publishing and quality control checks.

Liaison to Health Authorities regarding electronic submission requirements; capable of negotiating deliverables, if required.

Liaison to the RIM/Reg Technology function within Regulatory Operations on future system needs and/or upgrades to current systems.

Proactively engage with industry experts and/or regulatory agencies on new guidance and regulations impacting submissions and related technology/systems.

Perform impact analysis and ensure organization preparedness to meet new global requirements.

Interact with and manage external vendors on expectations, timelines, and quality of work.

Serve as a primary lead on global programs within R&D and Global Regulatory Affairs, including the ability to lead both strategy, program management and execution (i.e. RIM)

Core Competencies, Knowledge and Skill Requirements:

Customer focused.

Strong leadership skills with the ability to lead, train and mentor team members in multiple disciplines.

Excel at working in a team environment.

Capable of managing multiple projects and complex timelines.

Ability to problem solve under pressure.

Strong business acumen and ability to make sound decisions that contribute positively to the business.

Strong strategic skills including creativity and effectiveness in identifying and addressing operational challenges.

Ability to balance short-term needs with long-term vision.

Proven ability to deliver goals within a cross-functional team with a high level of professionalism.

Strong expertise and knowledge of the eCTD/CTD structure and submission data standards.

Functional knowledge of document management, and submission publishing software.

Extensive regulatory operations experience with electronic/paper submission requirements, submission publishing software, and submission dossier management.

Communication & Interpersonal Skills:

Excellent interpersonal, communication, analytical and organizational skills.

Skilled in conflict resolution/negotiation.

Fosters open communication; listens and facilitates discussion.

Demonstrate leadership capacity in a highly matrix working environment by interacting effectively with internal departments and external organizations.

Works independently under general supervision.

Ability to prioritize and handle multiple projects simultaneously.

Possess effective presentation skills with keen ability to engage and captivate audience

Requirements:

Bachelor's Degree required with 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. Master's Degree preferred.

Candidates must have experience and knowledge with CTD/eCTD and working knowledge of FDA, EMA and ICH regulatory submission guidance and regulations. Excellent oral and written communications skills are a must as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, company environment.

Travel, Physical Demands and Work Environment:

Business travel to be ~20% as required

Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)

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.

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