Global Regulatory Lead

CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we’re building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world.

The Director, Senior Global Regulatory Lead (Sr. GRL) is a key member of CSL’s Global Regulatory Strategy (GRS) organization and serves as the global regulatory leader for assigned products within the respective therapeutic area.

In this highly visible, strategic role, you will develop and lead innovative, science-driven global regulatory strategies across the product lifecycle, from early development through registration and post-marketing activities. You will serve as the primary Global Regulatory Affairs (GRA) representative on Product Strategy Teams (PSTs) and other cross-functional development teams, ensuring regulatory strategies are integrated into product development decisions and aligned with broader business objectives.

As a trusted regulatory partner, you will build and maintain productive relationships with global health authorities, particularly the FDA and EMA, while guiding regulatory teams through complex development and approval pathways. You will influence strategic decisions, anticipate regulatory challenges, and identify opportunities to accelerate the delivery of innovative therapies to patients.

Key Responsibilities:

• Develop Global Regulatory Strategy: Establish and lead integrated, science-based global regulatory strategies for assigned products, supporting development, registration, and post-marketing lifecycle activities while balancing innovation, patient needs, and business priorities.
• Lead Cross-Functional Regulatory Partnership: Serve as the primary GRA representative on Product Strategy Teams and partner with Clinical Development, Safety, Commercial, Research, and other key stakeholders to ensure regulatory considerations are incorporated into product strategy and decision-making.
• Drive Health Authority Engagement: Lead strategic relationships and interactions with key health authorities, including the FDA and EMA, and collaborate with regional regulatory partners to support successful regulatory outcomes across global markets.
• Provide Regulatory Leadership and Oversight: Lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned products, establishing priorities, coordinating deliverables, assigning responsibilities, and ensuring alignment across global regulatory functions.
• Influence Product Development Decisions: Serve as the primary GRA reviewer and, where appropriate, approver of key development deliverables, including protocols, Target Product Profiles (TPPs), and other strategic documents. Provide regulatory guidance to senior leadership and cross-functional teams.
• Lead Strategic Regulatory Deliverables: Oversee the development of key regulatory documents and initiatives, including Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and Global Regulatory Strategy Outlines.
• Drive Regulatory Intelligence and Innovation: Leverage competitive regulatory intelligence, emerging technologies, AI-enabled insights, business analytics, and specialized regulatory expertise to inform strategy, assess opportunities, and proactively address potential challenges.
• Promote Global Regulatory Alignment: Build strong relationships across Global Regulatory Strategy, including regional regulatory teams and Regulatory CMC, to promote consistency, knowledge sharing, and a unified global regulatory approach.
• Lead and Develop Talent (where applicable): Coach and develop Regional Regulatory Leads, establish clear performance expectations, foster accountability, and support succession planning and career growth.
• Champion CSL Leadership Capabilities: Demonstrate CSL's leadership capabilities by building partnerships, thinking strategically, driving outcomes, embracing agility, inspiring innovation, and cultivating talent.

Qualifications & Experience:

• Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline required.
• Advanced degree (MS, PhD, MD, DVM) or MBA preferred.
• Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, including at least 8 years in Regulatory Affairs.
• At least 5 years of experience supporting pharmaceutical or biological product development.
• Demonstrated experience leading teams, preferably with 5 years of direct or matrix leadership experience, including setting strategic direction, driving accountability, and developing talent.
• Strong knowledge of pharmaceutical and biological product development and regulatory requirements across multiple major regions, including the US, EU, and/or Japan.
• Demonstrated experience working directly with at least one major health authority, such as the FDA or EMA.
• Experience navigating complex, global, matrixed organizations and influencing cross-functional stakeholders.
• Strong clinical development or medical device expertise is highly desirable.

The successful candidate will bring:

• Strong strategic thinking and the ability to translate complex regulatory considerations into actionable development strategies.
• Excellent communication, influencing, and relationship-building skills, including the ability to engage effectively with senior leadership and health authorities.
• Sound judgment and confidence in making complex regulatory decisions and taking calculated risks.
• The ability to lead through influence, foster collaboration, and drive accountability across geographically dispersed teams.
• A patient-focused mindset and passion for advancing innovative therapies through successful development and approval.

The expected base salary range for this position at hiring is $242,000 - $270,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

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.

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.