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AD/Sr. Manager, Global Regulatory CMC Business Management

Company: BeiGene, Ltd.
Location: Cambridge
Posted on: June 24, 2022

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. General Description: The Sr. Manager of Global Regulatory CMC Business Management will be responsible for providing regulatory CMC project management for our fast-growing pipeline including small molecules and biologics across all regions. This position will work collaboratively with the global regulatory CMC project teams as well as the cross-functional departments (e.g. Regulatory Strategists, Quality, CMC, and Supply Chain) to ensure smooth and efficient implementation of functional goals by coordinating, prioritizing, and tracking of regulatory activities and submissions for both products in early and late stage development and post-approval phases. It will also maintain Standard Operating Procedures (SOPs), Work Instructions (WIs), and Best Practices, coordinate communication and training, and identify/develop fit-for purpose systems and tools to enable the Global Regulatory CMC to efficiently perform their daily tasks and comply with regulations. Essential Functions of the job: Follow the project management methodology and best practices to manage regulatory CMC projects, and ensure the action items are tracked, followed up, and completed on time. Work with Regulatory CMC project leads and provide stakeholders and senior management team the regulatory CMC activity and strategy update on a regular basis. Work with the Regulatory CMC teams and cross-functional groups to establish, facilitate implementation, and maintain SOPs, Wis, and Best Practices and optimize the business process based on regulatory and quality requirements. Assist the development and implementation of related regulatory strategies and processes through business solutions, e.g. tools or/and databases, etc., and identify and leverage new technology to continuously improve team efficacy and productivity. Take initiatives and work with cross-functional teams to implement systems and processes for new regulations (e.g. IDMP and KASA) to meet the mandate timelines. Support and maintain the CMC module documents for the team to create high-quality and submission-ready documents with the predefined structure and consistent formats. Set up a document repository for global regulatory CMC and project teams and manage access and folder structure. Help filing teams maintain submission content planning and track regulatory document versioning and registrations for IND/CTA, IMPD, NDA/BLA submissions. Manage the Global Regulatory CMC SharePoint sites and support the maintenance of the Tracking Sheets. Develop, maintain, and support the Regulatory CMC Intelligence databases to provide reliable, comprehensive, and up-to-date information to facilitate internal regulatory CMC strategy establishment. Help Global Regulatory CMC manage trainings, including onboarding, knowledge sharing, and continuous learning and career development for team members. Qualifications: Knowledge and Skills Preferred to have 8+ years of experience in the pharmaceutical, life sciences or related industry with knowledge of the end-to-end drug development process. Understand ICH guidelines and regional health authority regulations with the experience in the Regulatory Affairs, CMC, Quality, Supply Chain, or related areas. Familiarity with global regulatory submissions, including development and marketing drug applications (e.g. IND/CTA, BLA, NDA, MMA, and NDA) as well as the eCTD submission lifecycle. Proven track record of excellent innovation mindset and preferred to have technological background and regulatory technology expertise. Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines with proficient time management, risk management, and organization skills. Demonstrated work ethic, self-motivation, flexibility, resilience, and attention to detail in team environment across different time zones. Proficiency in project management methodologies and effectiveness in managing multiple projects with excellent verbal, written, negotiation, interpersonal communication, and change management skills. Proficiency in systems and tools for project management and document management, including MS Project, Smartsheet, SharePoint, Veeva, etc. Strong business intelligence and analytics skills to analyze raw information and deliver insights for better business solutions. Knowledge of business process/standard operating procedure and knowledge base. Ability to implement and manage regulatory systems and tools to meet business requirements by collaborating with IT and Quality departments. Proficiency in MS Office applications on the PC and deep understanding of document formatting and styles. Knowledge and experience to design and develop enterprise applications, document templates, MS Word add-Ins. Travel As needed. Supervisory Responsibilities: N/A 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 requests clarification as needed; 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 analyzes 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. 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, 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, Ltd., Cambridge , AD/Sr. Manager, Global Regulatory CMC Business Management, Executive , Cambridge, Massachusetts

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