SanMateoRecruiter Since 2001
the smart solution for San Mateo jobs

Business Project Manager, Regulatory Operations

Company: BeiGene
Location: San Mateo
Posted on: June 27, 2020

Job Description:

BeiGene 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.Position Summary:The Regulatory Technology team in BeiGene Regulatory Affairs Operations drives our regulatory technology strategy, by collaborating with cross functional teams (IT, QA, RA, etc.) to implement regulatory systems and provide support, including training to our end users. The Manager will provide global support to the Regulatory Affairs, Regulatory Operations and other cross-functional global submission filing stakeholders to support global regulatory filings (e.g. US, EU, APAC etc.). This role will work closely with the project team and business stakeholders in order to ensure systems and processes are compliant with ISO, ICH, FDA, and other regional regulatory requirements.Essential Functions of the Job:Provide expertise, guidance, and leadership in regulatory information management, submission publishing and validation, and regulatory system strategies.Maintain up-to-date knowledge of global standards and procedures for regulatory submissions, including eCTD, IDMP, and publishing standards.Analyze 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.Provide 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.Establish, update and implement Regulatory-required formats, templates, policies, standards, and procedures for regulatory submissions.Provide Business SME support for tools that manage R&D Submissions and Registrations.In partnership with IT, ensure that Regulatory technology requirements are incorporated and supported by both new systems and upgraded to existing systems.Provide recommendations in formulating new technology and guidance.Provide 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.Provide business user support and recommendations on regulatory specifications for submissions, and the ability of publishing tools and systems to support them.Support and expand existing tools and platforms.Develop and provide training on Regulatory technologies and 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.Perform project management functions from project planning phase through completion.Define, develop, and execute project plans (in collaboration with IT) specifying goals, strategy, resources, scheduling, identification of risks, and contingency plans.Support assigned projects and programs; including coordinating project meetings, updating project documentation, and monitoring project status.Provide a high level of support serving as the primary contact for the end users on all assigned projects.Qualifications:6+ years of R&D and pharmaceutical system support with technical or business administration and information management experience OR9+ years of technical support and information management experience (or 11+ without a Bachelor's degree)3+ years of experience in electronic document management (e.g. Veeva VAULT--, Documentum--, FirstDocs--) or global submission publishing and validation systems (e.g. Liquent InSight--, LORENZ docuBridge and eValidator--) (or 5+ years without a Bachelor's degree).Understanding of Regulatory end-to-end process from document authoring and management, submission publishing and validation, to regulatory information management and archive.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 Windows desktop applications and web applications including installation, upgrade, troubleshooting, and license management.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 cloud computing platforms, infrastructure, framework, security, and Software-as-a-Service (e.g. AWS and MS Azure).Strong knowledge of document management systems, document formatting and regulatory publishing software systems and process.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.Strong familiarity with project management and methodologies.Experience managing projects on-time within budget constraints (managing resources, deadlines, progress and quality).Education Required: Bachelor's degree or related experience is required. Computer science or information management field preferred.Computer Skills: Regularly required to operate standard office equipment (personal computer, photocopy machine, etc.)Travel for Work: Minimum travel requiredCompetencies: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.We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental 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.

Keywords: BeiGene, San Mateo , Business Project Manager, Regulatory Operations, Executive , San Mateo, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Executive Jobs


Operations Manager, Consumer Storage
Description: At Iron Mountain we protect what our customers value most, from the everyday to the extraordinary, while helping them bridge the physical and digital world. Our people have the opportunity to bring their (more...)
Company: Iron Mountain
Location: San Francisco
Posted on: 07/10/2020

Director, Academic Technology Services
Description: Posting Details Working Title Director, Academic Technology Services Classification Title Administrator II Job Summary Information Resources Technology IRT provides essential information technology (more...)
Company: California State University, Sacramento
Location: Sacramento
Posted on: 07/10/2020

Account Manager, Encapsulates & Inclusions
Description: Balchem Corporation Nasdaq:BCPC is a publicly traded global specialty chemicals company with 500 million plus in revenue and north of 2.5 billion market cap, having witnessed steady growth over the (more...)
Company: balchem
Location: Sacramento
Posted on: 07/10/2020


TEMP COMMUNITY DIRECTOR, COULD LEAD TO OTHER OPPORTUNITES IN THE COMPANY
Description: Work Location Metro Area: br br Bay Area E.Bay br br Full-Time/Part-Time: br br Full-time br br Regular/Temporary: br br Temporary br br Proposed Pay Rate: br br 30.00 Hourly (more...)
Company: FPI Management
Location: San Lorenzo
Posted on: 07/10/2020

Director, Projects Controls
Description: Job DescriptionThe Project Controls Director will support our Northwest and Canada Divisions covering projects in Northern California, Washington State, and Canada. This job is flexible to work in either (more...)
Company: Flatiron
Location: Benicia
Posted on: 07/10/2020

HUD experienced Assistant Manager needed!
Description: Work Location Metro Area: br br Bay Area San Francisco Co. br br Full-Time/Part-Time: br br Full-time br br Regular/Temporary: br br Regular br br Proposed Pay Rate: br br (more...)
Company: FPI Management
Location: San Francisco
Posted on: 07/10/2020

Psychiatry Nurse Manager
Description: A great opportunity with a top regional hospital in Northern California is now available for a qualified Nurse Manager of Inpatient Behavioral Health. br The Psych Nurse Manager is responsible for ensuring (more...)
Company: Nurse Management
Location: San Francisco
Posted on: 07/10/2020

Experienced Affordable Community Director with LIHTC/HUD
Description: Work Location Metro Area: br br Bay Area San Francisco Co. br br Full-Time/Part-Time: br br Full-time br br Regular/Temporary: br br Regular br br Proposed Pay Rate: br br (more...)
Company: FPI Management
Location: San Francisco
Posted on: 07/10/2020

AppD VP, Americas Services
Description: AppD Director, America Services br br About the roleReporting into our Vice President of Global Services, the VP, Americas Services will be tasked with running all facets of our services business (more...)
Company: AppDynamics
Location: San Francisco
Posted on: 07/10/2020

Registered Nurse Case Manager RN - Home Health and Hospice - Full Time
Description: Description br br Heartland Home Health Care and Hospice is part of the HCR ManorCare family, a leading provider of home health care, hospice care, skilled nursing, memory care and post-acute care.As (more...)
Company: HCR ManorCare
Location: El Cerrito
Posted on: 07/10/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

San Mateo RSS job feeds