GRA CMC Specialist

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 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

Education & Experience

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, 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.