GRA CMC Specialist

CSL•Waltham, MA

About The Position

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. This role defines 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. The Lead serves as the primary regulatory interface for plasma as regulatory starting material sourced from assigned countries or region and represents Global Regulatory Affairs CMC - Plasma Collection & Sourcing in internal and partner meetings for plasma sourced from assigned countries or regions. This role manages 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.