Senior Manager Global Regulatory Affairs CMC

Partner closely with CSL’s R&D, Manufacturing, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. Define global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological and non-biological products. Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. Promote strong cross-functional collaboration and effective communication across Global Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to drive alignment and support CSL’s strategic business objectives.

• Lead the global regulatory CMC strategy across the assigned development and commercial biological and non-biological product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
• Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports, and renewals.
• Ensure timely execution aligned with regulatory expectations and business goals.
• Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for biological and non-biological product-related change controls, including country-specific reporting category and detailed submission documentation requirements.
• Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its biological and non-biological product portfolio.
• Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.
• Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests.
• Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.
• Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders on regulatory requirements and their implications for project timelines, compliance, and business strategy.
• Contribute to the evaluation of new business opportunities in collaboration with development teams.
• Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.
• Provide 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.
• Maintain 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.
• Ensure regulatory policies and procedures are developed and implemented in accordance with applicable international standards and requirements.
• Support the creation and execution of regulatory policies, processes, and SOPs that meet global regulatory requirements while driving operational efficiency and effectiveness across Global Operations and its stakeholder network.
• Support the outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.

• A bachelor’s degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is strongly preferred.
• Over 5 years of progressive experience in regulatory roles within the biologics or plasma industry, demonstrating increasing levels of responsibility.
• 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.
• 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.
• Ensures accountability by following through on commitments and making sure others do the same, acting with a clear sense of ownership, and establishing clear responsibilities and processes for monitoring work and measuring results.
• Drives results by persisting in accomplishing objectives despite obstacles and setbacks, and helping others achieve results.
• Drives vision and purpose by talking about future possibilities in a positive way and creating organization-wide energy and optimism for the future.
• Instills trust by following through on commitments, being direct and truthful, and practicing what is preached.
• Communicates effectively in a variety of settings and encourages the open expression of diverse ideas and opinions.
• Builds effective teams by establishing common objectives, fostering open dialogue, and sharing wins and rewards.
• Drives engagement by aligning work with people's goals and motivators, empowering others, and showing a clear connection between motivators and organizational goals.
• Manages ambiguity by dealing comfortably with uncertainty and effectively handling risk.
• Collaborates by working cooperatively with others across the site, matrix, network, and enterprise to achieve shared objectives.
• Makes sound decisions, even in the absence of complete information, using analysis, wisdom, experience, and judgment.
• Has a global perspective, understanding the position of the organization within a global context and the impact of global trends.
• Is resilient under pressure, handles crises effectively, and maintains a positive attitude despite adversity.

CSL is committed to inclusion and belonging, celebrating differences and creating a culture of curiosity and empathy. CSL is an Equal Opportunity Employer and provides reasonable accommodations for individuals with disabilities during the application process.

CSL Behring is a global biotherapeutics leader focused on discovering, developing, and delivering innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. CSL Behring uses plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL, is headquartered in Melbourne, Australia, employs 32,000 people, and delivers therapies to people in more than 100 countries.