GRA CMC Specialist

ph3Position Purpose /h3pPartnering closely with global and regional Global Regulatory Affairs colleagues, as well as Global Operations stakeholders, to address regulatory strategy challenges and deliver innovative, timely regulatory CMC solutions that meet evolving regulatory and compliance requirements. Supporting digital innovation, enabling capital project initiatives, and managing strategic external partnerships by coordinating and aligning regulatory CMC strategies and activities across the enterprise. Ensuring operational alignment of Global Regulatory Affairs CMC activities and processes with RD Global Regulatory Affairs and within Global Operations business needs. This role promotes strong cross-functional collaboration and effective communication across Global Operations, RD, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives. /ph3Main Responsibilities and Accountabilities /h3ulliDevelop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, RD, Quality, Global Operations, and other business functions. /liliAssess and facilitate the use of digital innovation for Global Regulatory Affairs CMC, including AI/ML applications that manage or support regulatory submission, notification, assessment and intelligence activities. /liliCollaborate with Procurement, IT, external vendors, and RD Global Regulatory Affairs to implement next-generation solutions that enhance the generation of regulatory strategies and execution of regulatory operations. /liliDefine and monitor KPIs to measure impact of digital initiatives on operational efficiency indicators. /liliManage relationships with outsourcing vendors to support global regulatory CMC activities. /liliServe as contact for external partners, coordinating deliverables, timelines, and compliance across multiple projects and geographies. /liliMonitor performance, quality, KPIs, and regulatory readiness of outsourced operations, driving continuous improvement and risk mitigation strategies. /liliMonitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.). /liliEnsure timely dissemination of regulatory intelligence to internal stakeholders and integration into strategic planning. /liliCoordinate key regulatory CMC activities for the Global Regulatory Affairs CMC organization, including change control, due diligence (for potential acquisitions, licensing, and partnerships), template management for quality CTD sections, deviation support, inspection support, and others. /liliSupport the collaboration with CSL’s Corporate External Affairs organizationto support legislative and statutory initiatives to allow CSL to take an active leadership role in shaping policy and regulatory frameworks that impact the development, registration, and life-cycle management of plasma-derived therapies. /liliSupport the development of strategic and tactical plansfor Global Regulatory Affairs CMC, advising senior leadership on regulatory requirements and their implications for project timelines, compliance, and business strategy. /liliContribute to the evaluation of new business opportunities in collaboration with development teams. /liliEnsure regulatory policies and procedures are developed and implementedin accordance with applicable international standards and requirements. /liliSupport the the creation and execution of regulatory policies, processes, and SOPsthat meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network. /liliSupport the execution of the outsourcing of regulatory activities, including performance monitoring and quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements. /li /ulh3Position Qualifications and Experience Requirements /h3h3Education Experience /h3pA bachelor’s degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is preferred. /ppOver 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility. /ppStrong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management. /ppProven expertise in authoring, reviewing, and managing regulatory submissions at both federal and state levels, ensuring accuracy, compliance, and timely delivery. /ppDemonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders. /ppSkilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence. /ppExceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively. /ppCommitted to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs. /ppAbility to use precedent and previous experience to develop innovative and flexible approaches to achieve goals. /ph3Competencies /h3ulliEnsures 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; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work. /liliDrives Results: Has a strong bottom-line orientation; Persists in accomplishing objectives despite obstacles and setbacks; Has a track record of exceeding goals successfully; Pushes self and helps others achieve results. /liliDrives 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 way everyone can relate to; Creates organization-wide energy and optimism for the future; Shows personal commitment to the vision. /liliInstills Trust: Follows through on commitments; Is seen as direct and truthful; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions. /liliCommunicates Effectively: Is effective in a variety of communication settings: one‑on‑one, small and large groups, among diverse styles and position levels, with internal and external stakeholders/audiences. Attentively listens to others; Adjusts to fit the audience and the message; Provides timely and helpful information to others across the organization; Encourages the open expression of diverse ideas and opinions. /liliBuilds Effective Teams: Establishes common objectives and a shared mindset; Creates a feelings of belonging and strong team morale; Shares wins and rewards team efforts; Fosters open dialogue and collaboration among the team. /liliDrives Engagement: Structures the work so it aligns with people's goals and motivators; Empower 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. /liliManages 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. /liliCollaborates: Works cooperatively with others across the site, matrix, network and enterprise to achieve shared objectives; Represents own 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. /liliDecision 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 uses appropriate decision-making criteria and principles; Recognizes when a quick 80% solution will suffice. /liliGlobal 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. /liliBeing Resilient: Is confident under pressure; Handles and manages crises effectively; Maintains a positive attitude despite adversity; Bounces back from setbacks; Grows from hardships and negative experiences. /li /ulh3About CSL Behring /h3pCSL 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 and CSL Plasma at /ph3Our Benefits /h3pFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL. /ph3You Belong at CSL /h3pAt 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 /ppEqual Opportunity Employer CSL is an Equal Opportunity Employer. /ppIf you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit /ppCSL 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 click here. /ppCSL Global Privacy Notice for Job Applicants and Candidates /p /p #J-18808-Ljbffr