GRA CMC Specialist

CSL Behring; False Pass (AK); On-site; USD 150,000 - 190,000; Full time

Job summary

CSL Behring seeks an experienced Regulatory CMC professional to align global strategies for biologics and plasma-derived therapies. You will partner with Global Regulatory Affairs, Global Operations, and R&D to deliver compliant, timely CMC submissions and lifecycle management.

The role emphasizes digital optimization, vendor management, and policy shaping to support CSL's strategic objectives while ensuring alignment with international standards and regulatory requirements.

Qualifications

• Bachelor's degree in biological or chemical sciences required.
• 5+ years in regulatory roles within biologics or plasma industries.
• Strong knowledge of global regulations and international standards governing drug product development, manufacture, registrations, and lifecycle management.
• Experience authoring and managing regulatory submissions at federal and state levels.
• Proven ability to lead cross-functional teams and collaborate with key stakeholders.

Responsibilities

• Develop global regulatory CMC strategies for enterprise initiatives in collaboration with Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, and Global Operations.
• Assess and facilitate digital innovation for Global Regulatory Affairs CMC, including AI/ML applications for regulatory submission and regulatory intelligence.
• Manage relationships with outsourcing vendors and external partners, coordinating deliverables and timelines across geographies.
• Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.).
• Coordinate key regulatory CMC activities including change control, due diligence, template management for CTD sections, deviation support, and inspection support.
• Support collaboration with Corporate & External Affairs to shape policy and regulatory frameworks affecting lifecycle management of plasma-derived therapies.
• Contribute to strategic and tactical plans for Global Regulatory Affairs CMC and advise senior leadership on regulatory implications for timelines and business strategy.

Skills

Regulatory strategy

Cross-functional leadership

Global regulatory affairs

Regulatory submissions

Education

Bachelor's degree in biological or chemical sciences

MS/PhD preferred

Job description

Position Purpose

Partnering 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 R&D Global Regulatory Affairs and within Global Operations business needs.

This role promotes 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.

Main Responsibilities and Accountabilities

• Develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects through collaboration with functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
• Assess 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. Collaborate with Procurement, IT, external vendors, and R&D Global Regulatory Affairs to implement next‑generation solutions that enhance the generation of regulatory strategies and execution of regulatory operations. Define and monitor KPIs to measure impact of digital initiatives on operational efficiency indicators.
• Manage relationships with outsourcing vendors to support global regulatory CMC activities. Serve as contact for external partners, coordinating deliverables, timelines, and compliance across multiple projects and geographies. Monitor performance, quality, KPIs, and regulatory readiness of outsourced operations, driving continuous improvement and risk mitigation strategies.
• Monitor, interpret, and communicate evolving global CMC regulations (FDA, EMA, PMDA, NMPA, etc.). Ensure timely dissemination of regulatory intelligence to internal stakeholders and integration into strategic planning.
• Coordinate 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.
• Support the collaboration with CSL's Corporate & External Affairs organization to 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.
• Support the development of strategic and tactical plans for Global Regulatory Affairs CMC, advising senior leadership 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.
• 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 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.

Position Qualifications and Experience Requirements

• A bachelor's degree in biological or chemical sciences, or a related field is required; an advanced degree (e.g., MS, PhD) is 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 at both federal and state levels, 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