GRA CMC Specialist

CSL•Waltham, MA

23h

About The Position

The Head of Global Regulatory Affairs CMC - Network Strategy & Operation is responsible for 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. This role supports digital innovation, enables capital project initiatives, and manages strategic external partnerships by coordinating and aligning regulatory CMC strategies and activities across the enterprise. It ensures 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.

Requirements

A bachelor’s degree in biological or chemical sciences, or a related field is required.
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, 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.

Nice To Haves

An advanced degree (e.g., MS, PhD) is preferred.

Responsibilities

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.