Senior Manager Global Regulatory Affairs CMC

CSL•Waltham, MA

About The Position

The Senior Manager Global Regulatory Affairs CMC is responsible for developing and leading global regulatory strategies for an assigned portfolio of biological and non-biological products. The role partners with R&D, Manufacturing, Quality, Global Operations, Regulatory Affairs, and other CSL stakeholders to address regulatory strategy challenges and deliver timely solutions that meet evolving CMC regulatory and compliance requirements. The position manages the development and submission of CMC regulatory materials, provides regulatory guidance across the organization, and represents CSL in official CMC interactions with regulatory agencies. It also supports regulatory policies, processes, procedures, and outsourced regulatory activities, while fostering cross-functional collaboration and alignment with CSL’s business objectives.

Requirements

Bachelor’s degree in biological or chemical sciences, or a related field.
More than 5 years of progressive regulatory experience in the biologics or plasma industry.
In-depth knowledge of global regulations and international standards governing drug product development, manufacture, registration, and lifecycle management.
Expertise in authoring, reviewing, and managing regulatory submissions for accuracy, compliance, and timely delivery.
Ability to lead cross-functional teams and collaborate effectively with stakeholders.
Ability to motivate, mentor, and guide diverse teams in a matrixed organization.
Exceptional oral and written communication skills, including the ability to negotiate, influence, and represent regulatory positions.
Commitment to compliance, integrity, and adaptability, with the ability to align regulatory strategy with changing business needs.
Ability to use precedent and prior experience to develop innovative and flexible approaches.
Demonstrated competencies include accountability, results orientation, vision, trust, effective communication, team building, engagement, ambiguity management, collaboration, decision quality, global perspective, and resilience.

Nice To Haves

An advanced degree, such as an MS or PhD, is strongly preferred.

Responsibilities

Lead global regulatory CMC strategy for an assigned development and commercial portfolio of biological and non-biological products.
Manage development and submission of compliant CMC regulatory submissions and components, including marketing applications, clinical trial applications, variations or supplements, periodic compliance reports, and renewals.
Ensure accurate, timely change-control assessments in CSL’s quality management system, including country-specific reporting categories and submission documentation requirements.
Use external insights to refine strategies and develop innovative regulatory approaches for the product portfolio.
Represent CSL in official regulatory CMC capacities and interactions with regulatory agencies; maintain regulator relationships and ensure timely responses to inquiries and requests.
Develop strategic and tactical plans, advise leadership and stakeholders on regulatory requirements and impacts, and contribute to assessing new business opportunities.
Provide regulatory consultation to internal functions, including Global Operations, R&D, and IT, on business processes that support regulatory compliance and operational excellence.
Provide strategic and tactical regulatory guidance, contribute to problem-solving, assess alternative solutions, and prepare contingency plans while meeting regulations.
Maintain relationships with regional and local regulatory teams to support compliance and ethical conduct across regulatory activities.
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 requirements and improve operational efficiency and effectiveness.
Support outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant service delivery.