GRA CMC Specialist

BioSpace; Waltham (MA); On-site; USD 150,000 - 190,000; Full time

Job summary

CSL Behring in the United States seeks a senior regulatory affairs professional to develop global regulatory CMC strategies for enterprise-wide CAPEX and compliance projects, collaborating with Global Regulatory Affairs CMC, R&D, Quality, and other functions.

You will lead digital innovation, oversee outsourcing vendors, monitor global regulations (FDA, EMA, PMDA, NMPA), coordinate change control, due diligence, and regulatory submissions, and advise senior leadership on timelines and risk.

Qualifications

• Bachelor's degree in biological or chemical sciences required; MS/PhD preferred.
• Over 5 years of progressive regulatory experience in biologics or plasma.
• Deep knowledge of global regulations governing drug development and lifecycle.

Responsibilities

• Develop global regulatory CMC strategies for enterprise-wide projects with cross-functional teams.
• Advise on regulatory intelligence and ensure alignment with strategic plans.
• Manage outsourcing vendors and coordinate deliverables, timelines, and compliance.
• Monitor regulatory developments (FDA, EMA, PMDA, NMPA) and communicate implications to stakeholders.
• Lead change control, due diligence, and template management for CTD sections; support inspections.

Skills

Regulatory affairs

CMC

Global regulations

Vendor management

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in biological/chemical sciences

MS/PhD preferred

Job description

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

organizationto 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 plansfor 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 implementedin accordance with applicable international standards and requirements.

Support the the creation and execution of regulatory policies, processes, and SOPsthat 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.

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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.