GRA CMC Specialist
CSL Plasma Inc.
- # GRA CMC SpecialistApplylocations: Americas, US-PA, King of Prussia, CSL Behring: EMEA, CH, Kanton Bern, Bern, CSL Behring: Americas, US-MA, Waltham, CSL Behringtime type: Full timeposted on: Posted Todayjob requisition id: R-275244Position Purpose The Lead, Global Regulatory Affairs CMC - Plasma Collection & Sourcing – EU & International is responsible for: Partnering closely with Plasma Operations to address regulatory strategy challenges and deliver innovative, timely solutions that meet evolving regulatory and compliance requirements. Defining regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s plasma collection centers in the EU, as well as third-party plasma sourcing. Serving as the primary regulatory interface for plasma as regulatory starting material sourced from assigned countries or region. Representing Global Regulatory Affairs CMC - Plasma Collection & Sourcing in internal and partner meetings for plasma sourced from assigned countries or regions. Managing all relevant regulatory aspects for collected or sourced plasma as a starting material for CSL’s commercial plasma-derived therapies, and products provided to third party customers. This role promotes strong cross-functional collaboration and effective communication across Plasma Operations, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives. Main Responsibilities and Accountabilities Partner with internal and external stakeholders to promote understanding of regulatory requirements and strategies for the assigned countries or region. Facilitate information exchange and knowledge sharing across plasma groups to support globally harmonized regulatory strategies. Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations. Maintains an ongoing and interactive relationship with regional and local regulatory teams to assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards. Providing tactical and strategic regulatory leadership, including risk assessments and mitigation planning. Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for plasma-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements. Manage the planning and execution of Plasma Master File (PMF) or abbreviated plasma information submissions. Generate, maintain, and communicate a submission schedule for each ANZAP plasma source, covering new applications, updates, variations, renewals, and commitments. Manage completion of PMF questionnaires with third-party plasma suppliers. Provide regulatory support during inspections by health authorities, assess and communicate inspection findings, and support CAPA projects as needed. In close collaboration with local and regional Regulatory Affairs staff, contribute to and participate in Health Authority meetings for plasma-related matters. Support the creation and maintenance of a regulatory intelligence database related to Health Authority interactions. Evaluate draft guidelines, conduct impact assessments, coordinate stakeholder reviews, and develop final response documents to establish common regulatory interpretations. Support the preparation and submission of plasma information in support of tender applications. Ensure regulatory policies and procedures are developed and implemented in accordance with applicable EU, international, and industry (ISO, IQPP) standards and requirements. Support the develops and implementation of systems necessary to report viral marker data to health authorities. Establishes and maintains relationships with regulatory agencies. Develops internal communication strategies to ensure timely resolution of regulatory issues. Provide comprehensive regulatory support to ensure readiness and compliance during Health Authority inspections, facilitating successful outcomes and alignment with applicable standards. Provide consultation and final review of the site master files and submit to applicable health authorities. Ensure regulatory activities comply with CSL’s Code of Responsible Business Practice, Global Quality Policies, GMP requirements, and Health, Safety & Environment Management System. Position Qualifications and Experience Requirements Education & Experience A bachelor’s degree in biological sciences or a related field is required; an advanced degree (e.g., MS, PhD) is preferred. Over 5 years of regulatory experience within the biologics or plasma industry, demonstrating increasing levels of responsibility. Strong technical foundation with in-depth knowledge of EU regulations governing plasma collection, sourcing, and manufacturing desired. Strong technical foundation with in-depth knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and life-cycle management. Proven expertise in authoring, reviewing, and managing regulatory submissions, ensuring accuracy, compliance, and timely delivery. Demonstrated ability to lead cross-functional teams and collaborate effectively with key stakeholders across regulatory, quality, medical, operational, and IT functions. Skilled in motivating, mentoring, and guiding diverse teams within a matrixed organizational structure, fostering a culture of accountability and excellence. Exceptional oral and written communication skills, with a strong ability to negotiate, influence, and represent regulatory positions effectively. Committed to the highest standards of compliance, integrity, and adaptability, with a strong focus on aligning regulatory strategy with evolving business needs. Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve goals. 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; Establishes clear responsibilities and processes for monitoring work and measuring results; Designs feedback loops into work. Drives 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. 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 way everyone 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; Keeps confidences; Practices what he/she preaches; Shows consistent between words and actions. Communicates 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. Builds 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. 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, 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. 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 uses appropriate decision-making criteria 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; Maintains a 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 and CSL Plasma at Benefits**For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.**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 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
- J-18808-Ljbffr CSL Plasma Inc.
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