北京招聘

Responsibilities:
As the lead of Regulatory you will help to establish the team within BeiGene. Job duties and functions include:
?Creating a Regulatory Intelligence Strategic roadmap and ensuring that BeiGene’s strategy and business requirements are aligned to that roadmap.
?Performing impact assessments and triaging key legislations and regulatory guidelines in partnership with other functions to evaluate the effect of those policies on BeiGene’s processes and functions
?Liaises with other functions and lead the coordination of internal commenting process for Health Authorities (HAs) for policies that have open consultations that impact BeiGene.
?Maintains awareness of current and evolving guidelines, indications of interest and regulatory hot topics and prioritizes dissemination of information as dictated by business requirements.
?Develops, implements and maintains systems for monitoring, capturing, analyzing and communicating RI. Monitors primary and secondary sources of RI information, e.g. agency websites, databases, competitor websites, journals. Summarizes, analyses and distributes relevant RI information and potential impact on BeiGene. Where relevant provides impact analysis, or coordinates provision of impact analysis, to the wider audience.
?Maintains knowledge of competitor products and identifies and communicates RI (key milestones and submissions) on competitor products and competitor development programmes to key customers.
?Provides responses to ad-hoc information requests and other regulatory enquiries. Monitors the current regulatory environment for opportunities: externally to shape future regulations, guidance and legislation; internally to shape policy and assist in making informed business decisions.
?Develops and maintains relationships with external industry associations/forums and other pharmaceutical companies to exchange information. Where required attends relevant regulatory conferences (e.g. Annual DIA meeting) and provides feedback to the department
?Provides RI updates to the Regulatory Leadership Team
?Produce regulatory intelligence reports or deliverables as it relates to project or process strategies
?Create, update and maintain SOP/WI which impact to regulatory affairs functions.
?Ensure that the SOP/WIs are executable
?Provide trainings to RA colleagues and other related functions.
?Schedule audit plan and do audit as plan according to risk management.
Core Competencies, Knowledge and Skill Requirements
?Degree in biological/life sciences, pharmacy or medicine.
?Experience in a RI role a plus and significant relevant professional expertise in other RA roles or other relevant industry experience is advantageous.
?Understanding of regulatory environment in the US and EU is essential.
?Excellent written communication skills and ability to effectively communicate complex issues while working both within the group and across cross functional groups.
?Demonstrated effectiveness in cooperation and teamwork with judgment/problem solving and analytical skills and excellent interpersonal skills.
?Demonstrated ability to lead teams towards defined goals.
?Proactively seeks and finds information.
?Ability to critically analyse complex and/or ambiguous information and assess impact on products and processes.
?Works independently or with minimal supervision and is accountable for their output.
?Problem solving, strategic thinking skills with ability to impact and influence.
?Meticulous attention to detail with accuracy and quality.
?Ability to understand and effectively relate to external and internal customers.
?High integrity to maintain confidential and proprietary information.
?Organized and IT literate.
职位要求：
Communication & Interpersonal Skills
?Resilient profile with the ability to deliver in an ambiguous environment
?Ability to engage and manage multiple stakeholders to achieve the objective
?Curious with learning agility
?Operationally excellent
?Organized with systematic approach to prioritization
?Process orientated to achieve the business objective
?Ability to work in fast-changing and developing environment
Requirements
?8+ years of relevant experience with bachelor’s Degree or
?6+ years of relevant experience with Master or MBA
?Experience should include 3 years of participation in cross-functional project management activities.
?PMP or similar certification preferred
?Working knowledge with common project management systems required
?3 to 4 years of prior job experience preferred in a pharmaceutical project management role, working with multi-department/multi-functional teams
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
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, 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 budget.
Computer Skills:
?Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Travel:
?Must be willing to travel approximately 10-20%
?Ability to work on a computer for extended periods of time

百济神州是一家立足于科学的全球性生物科技公司，专注于开发创新、可负担的药物，旨在为全球患者改善治疗效果，提高药物可及性。目前公司广泛的药物组合包括40多款临床候选药物。公司通过加强自主研发能力和合作，加速推进多元、创新的药物管线开发。我们致力于在2030年前为全球20多亿人全面改善药物可及性。百济神州在全球五大洲打造了一支超过8,000人的团队。