Regulatory Technology Manager

Beigene, Ltd. San Mateo , CA 94401

Posted 3 months ago

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 2,200 employees in China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, please visit www.beigene.com.

Position Summary:

The Manager, Regulatory Technology, Regulatory Affairs Operations is responsible for providing technical and system support to the growing Regulatory Operations team in BeiGene. This person will help to establish the Regulatory Technology Function. This position provides global support to the Regulatory Affairs and Regulatory Operations organization with an immediate focus working on project for US and Pacific, and other regional regulatory filings. This position will collaborate closely with the Information Technology team to contribute to the overall client's technology strategy portfolio and ensure system and processes are implemented in compliance with ISO, FDA, Sarbanes-Oxley and other regulatory requirements.

Essential Duties & Responsibilities (Primary):

  • Provides Business SME support for Regulatory Affairs in the use of systems, and development and maintenance of supporting information related to the use of Regulatory technology.

  • Establishes, updates and implements Regulatory-required formats, templates, policies, standards, and procedures for regulatory submissions.

  • Provides Business SME support for tools that manage R&D Submissions and Registrations.

  • In partnership with IT, ensures that Regulatory technology requirements are incorporated and supported by both new systems and upgraded to existing systems.

  • Provides recommendations in formulating new technology and guidance.

  • Provides recommendations on the approach for the application of expert knowledge of global regulatory requirements for systems or policies with all contributing functions that ensure submission compliance.

  • Provides Business User support and recommendations on regulatory specifications for submissions, and the ability of publishing tools and systems to support them.

  • Maintains up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP; Publishing standards and analyzes new and revised guidance, advises regulatory management of new requirements, and recommends course of action.

  • Evaluate new tools and technologies and provide direction and support to the team on how to build these technologies into a Regulatory system portfolio.

  • Support and expand existing tools and platforms.

  • Develop and provide training on Regulatory technologies

  • Provide expertise, guidance, and leadership in Regulatory Information Management (RIM), and submission production and validation tools and strategies, to assist members of Regulatory Affairs in submission preparation and delivery.

  • Work across geographic regions to ensure support and functional needs are met.

  • Represent the needs of Regulatory Affairs system objectives in cross-functional teams.

Core Competencies, Knowledge and Skill

Requirements:
  • Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.

  • Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Experience with those would be a huge plus.

  • Knowledge of database analysis, design, and maintenance

  • Knowledge and/or experience with the Software development Lifecyle [SDLC] and IEEE standards as they pertain to the SDLC

  • Knowledge and/or experience with computer validation quality assurance for the Pharma/Biotech industry

  • Understanding of TCP /IP networking environments

  • Functional knowledge of document management, formatting and publishing software systems

  • Understanding of the drug development process

  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

Communication & Interpersonal

Skills:
  • Excellent interpersonal, communication, analytical and organizational skills.

  • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.

  • Team player capable of managing multiple projects and complex timelines in a team environment

  • Ability to problem solve and trouble shoot under pressure

  • Works independently under general supervision.

  • Ability to prioritize and handle multiple projects simultaneously.

Education: Bachelor's degree or related experience is required. Computer science field preferred.

Experience:

  • 6+ years of R&D and pharmaceutical technical support and information management experience or

  • 9+ years of technical support and information management experience or

  • 11+ years of technical support and information experience without a Bachelor's degree or

  • 3+ years of experience in electronic document management {or 5+ years without a Bachelor degree).

  • Experience in the preparation and submission of documents using regulatory/document management systems {e.g. VAULT, Documentum, FirstDocs, Publishing Tools, and Validation tools) is highly preferred.

Competencies:

Ethics

  • Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.

Planning/Organizing

  • Prioritizes and plans work activities; Uses time efficiently; Completes administrative tasks correctly and on time; Follows instructions and responds to management direction.

Communication

  • Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations; Writes clearly and informatively; Able to read and interpret written information.

Teamwork

  • Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed; Contributes to building a positive team spirit; Shares expertise with others.

Adaptability Able to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Technical Skills

  • Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability

  • Follows instructions and responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality

  • Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical

  • Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving

  • Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management

  • Communicates changes and progress; Completes projects on time and within budget.

BeiGene Is An Equal Opportunity Employer

BeiGene is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristics protected by law. As a federal contractor, BeiGene has established affirmative action programs to ensure non-discrimination and affirmative action in BeiGene's policies and practices for qualified women, minorities, protected veterans, and individuals with disabilities. The narrative portions of BeiGene's affirmative action plans for individuals with disabilities and veterans are available for inspection at our offices during normal business hours. Employees and applicants interested in inspecting these plans should contact our Human Resources department by email at us.hr@beigne.com for assistance.

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Regulatory Technology Manager

Beigene, Ltd.