The Global Regulatory Affairs CMC - Decision Support Lead is responsible for:
Providingcomprehensive administrative support to the Head of Global Regulatory Affairs CMCtoenablethe Head of Global Regulatory Affairs CMC to focus on strategic priorities and organizational leadership. This role requires exceptional attention to detail,strong communicationskills,maintainingthe highest level of confidentiality,and the ability to manage multiple prioritiessimultaneously.
Providing targeted administrative support to theGlobal Regulatory Affairs CMCleadership team,ensuring the efficient operation of departmental activities.Tracks departmental business actions, goals,objectives, KPIs,and commitments to internal stakeholders.
Supports the Head of Global Regulatory Affairs CMC in department-wide resource planning and forecasting through data-driven resource analysis. Partners with finance, HR, and project managers to support workforce planning, hiring forecasts, and contractor use.
This role exercises strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to meet the administrative and operational business needs of the department.
Main Responsibilities and Accountabilities
Proactively manage the Head of Global Regulatory Affairs CMC's calendarandschedule meetingsas directed,.Know the manager's short- and long-termobjectivesas well as the respective departmental stakeholders to ensureappropriateprioritizationof meetings, reschedulingofmeetings, and avoidance of meeting conflicts. Proactively rebalance weekly meeting load and secure free time slots for focused work.
Preparemeetingagendas, take meeting minutes, and track action items to ensuretimelyfollow-uporconslusions.Proactively communicate upcoming due dates and deadlines to the respective departmental colleagues.
Maketravel arrangementsfor individual andgroupdtravel, including air and ground transportation, lodging, restaurant reservations, meeting room booking, checking visa requirements, and others.Coordinate departmental meetings, events, and workshops, includinglogisticsand materials preparation.Prepare the manager's expense reports.
Prepare and edit correspondences,announcements,presentations, and other documents withthehighestdegree of accuracy and professionalism.
Assistin on-boarding of newemployessand off-boarding ofexitingemployees. Prepare welcome and on-boarding materials, arrange office and systems access, coordinate introductions, track on-boarding and training completion progress, update internal directories and organizational charts,andassitwith earlyadministrativetasks.
Assitin developing administrative project plans, coordinate kick-offactivitiesand recurring meetings, and prepare required resources andsystemsaccess. Develop timelines and schedules,trckprogress, and proactively communicate any conflicts or delays.
Support theGlobal Regulatory Affairs CMCleadership team in scheduling andfacilitatingrecurring departmental meetings(e.g., leadership team meeting, change control review meeting, regulatory commitment review, etc.)and their respective agendas and action/conclusionsummaries.
ManageTeamAssuranceplatform for theGlobal Regulatory Affairs CMCorganization to enable the leadership team to connectwith frontline teams in real time, align daily work with strategic goals, and foster a culture of continuous improvement. Manage entries,remindersand follow-ups.
Execute data collections andentries, andprepare and manage dashboards as well as analysis reports using Microsoft's Power BI. Proactively enhance Power BI user skills andexpertisethrough continuous learning (e.g., online classes).
Position Qualifications and Experience Requirements
Education & Experience
High school diploma or equivalent (minimum); bachelor's degree in business administration, life sciences, or a related field often preferred.
Additionalcertifications in administration, project management, or relevant software (e.g., Microsoft Office Specialist, CAP) areadvantageous.
Familiarity with the pharmaor biotechnological industry, and comfortableworking with scientific, drug manufacturing, orregulatory terminologyis desired; prior experience working in the pharmaor biotechnological industryis preferred.
Exceptional oral and written communication skills.
Provenproficiencyin using and applying Microsoft Excel, PowerPoint, Word, OneNote, SharePoint, Outlook, Power BI, Teams, Planner,List, SAPConcur, as well asAdobe Acrobat or similar for creating/editing PDFs.Abilityto quickly adapt to new software platforms isdesirable.
Committed to the highest standards ofconfidentiality,compliance, integrity, and adaptability.
Competencies
Ensures Accountability: Follows through on commitments and makes sure others do the same; Acts with a clear sense of ownership; Takes personal responsibility for decisions, actions, and failures;Establishesclear responsibilities and processes formonitoringwork and measuring results; Designs feedback loops into work.
Drives Results: Has a strong bottom-line orientation; Persists inaccomplishingobjectivesdespite obstacles and setbacks; Hasa track recordof exceeding goals successfully; Pushes self and helps others achieve results.
Drives Vision & Purpose: Talks about future possibilities in a positive way; Creates milestones and symbols to rally support behind the vision; Articulates the vision in a wayeveryone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision.
Instills Trust: Follows through on commitments; Is seen as direct and truthful; Keepsconfidences; Practices what he/she preaches; Shows consistent between words and actions.
Communicates Effectively: Is effective in a variety of communication settings: one-on-one,smalland large groups, among diverse styles and position levels, with internal and external stakeholders/audiences.Attentivelylistensto others; Adjusts to fit the audience and the message; Providestimelyand helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions.
Drives Engagement: Structures the work so it aligns with people's goals and motivators; Empowers others; Makes each person feel his/her contributions are important; Invites input and shares ownership and visibility; Shows a clear connection between people's motivators and the organizational goals.
Manages Ambiguity: Deals comfortably with the uncertainty of change; Effectively handles risk; Can decide and act without the total picture; Is calm and productive, even when things are up in the air; Deals constructively with problems that do not have clear solutions or outcomes.
Collaborates: Works cooperatively with others across the site, matrix,networkand enterprise to achieve sharedobjectives;Representsown interests while being fair to others and their areas; Partners with others to get work done; Credits others for their contributions and accomplishments; Gains trust and support of others.
Decision Quality: Makes sound decisions, even in the absence of complete information; Relies on a mixture of analysis, wisdom, experience, and judgment when making decisions; Considers all relevant factors and usesappropriate decision-makingcriteria and principles; Recognizes when a quick 80% solution will suffice.
Global Perspective: Looks toward the broadest possible view of an issue or challenge; Thinks and talks in global and network terms; Understands the position of the organization within a global, network and enterprise @context; Knows the impact of global trends on the organization.
Being Resilient: Is confident under pressure; Handles and manages crises effectively;Maintainsa positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/ .
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (https://www.csl.com/careers/your-well-being) .
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement .
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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement
