GRA CMC Specialist

CSL•Waltham, MA

About The Position

The Team Lead, Global Regulatory Affairs CMC - Biological & Non-Biol. Products is responsible for partnering closely with CSL’s R&D, Manufacturing, Quality, Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving CMC regulatory and compliance requirements for the assigned product portfolio. This role defines global regulatory strategies, objectives, and policies that advance and support the development, registration, and lifecycle management of CSL’s biological & non-biol. products. The Team Lead represents CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies. 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 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 strongly preferred.

Responsibilities

Lead the global regulatory CMC strategy across the assigned development and commercial biological & non-biol. product portfolio, collaborating closely with cross-functional leaders in Global Regulatory Affairs CMC, Global Regulatory Affairs, R&D, Quality, Global Operations, and other business functions.
Manage the development and submission of high-quality, compliant CMC regulatory submissions and submission components, including new marketing applications, clinical trial applications, variations/supplements, periodic compliance reports and renewals. Ensure timely execution aligned with regulatory expectations and business goals.
Ensure accurate and timely change control assessments of change control notifications in CSL’s quality management system for biological & non-biol. product-related change controls. This includes the country-specific reporting category and detailed submission documentation requirements.
Leverage external insights to refine strategies and implement innovative regulatory approaches that enhance CSL’s competitive positioning for its biological & non-biol. product portfolio.
Represent CSL in official regulatory CMC capacities, acting as an authorized official or responsible person in interactions with regulatory agencies.
Maintain strong, positive relationships with regulators and ensure timely responses to inquiries and requests.
Facilitate timely decision-making and guidance from health authorities through effective communication and relationship management.
Develop strategic and tactical plans for Global Regulatory Affairs CMC, advising Global Regulatory Affairs CMC leadership and CSL stakeholders 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.
Provide regulatory consultation to internal CSL functions, including Global Operation functions, R&D, and IT, to support the design and implementation of business processes that ensure regulatory compliance and operational excellence.
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.
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 outsourcing of regulatory activities, including submission quality assurance, to ensure timely and compliant delivery of services aligned with business and regulatory requirements.