Global Regulatory Lead
About The Position
The Director, Senior Global Regulatory Lead (Sr. GRL) is a key member of CSL’s Global Regulatory Strategy organization and serves as the global regulatory leader for assigned products within a therapeutic area. The role develops and leads science-driven global regulatory strategies across the product lifecycle, from early development through registration and post-marketing activities, aligning regulatory approaches with patient needs and business objectives. The Sr. GRL is the primary Global Regulatory Affairs representative on Product Strategy Teams and other cross-functional development teams. The role partners with functions including Clinical Development, Safety, Commercial, and Research, and builds relationships with global health authorities, particularly the FDA and EMA. It also leads the Global Regulatory Affairs Strategy Team for assigned products, oversees strategic regulatory deliverables, and guides regulatory decisions and product development. Depending on the role, the Sr. GRL may lead and develop Regional Regulatory Leads. CSL is a global biotherapeutics company focused on developing and delivering therapies for patients. The position is hybrid, with three days onsite per week, and is located in King of Prussia, Pennsylvania; Waltham, Massachusetts; Maidenhead, United Kingdom; or Zurich, Switzerland.
Requirements
- Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline.
- At least 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.
- Experience leading teams; preferably 5 years of direct or matrix leadership, 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 strategic thinking and ability to translate complex regulatory considerations into actionable development strategies.
- Excellent communication, influencing, and relationship-building skills, including effective engagement with senior leadership and health authorities.
- Sound judgment and confidence making complex regulatory decisions and taking calculated risks.
- Ability to lead through influence, foster collaboration, and drive accountability across geographically dispersed teams.
- Patient-focused mindset and passion for advancing innovative therapies through development and approval.
Nice To Haves
- Advanced degree (MS, PhD, MD, or DVM) or MBA.
- Strong clinical development or medical device expertise is highly desirable.
Responsibilities
- Develop and lead integrated, science-based global regulatory strategies for assigned products, covering development, registration, and post-marketing lifecycle activities.
- Represent Global Regulatory Affairs on Product Strategy Teams and partner with Clinical Development, Safety, Commercial, Research, and other stakeholders to incorporate regulatory considerations into product strategy and decisions.
- Lead strategic relationships and interactions with health authorities, including the FDA and EMA, and work with regional regulatory partners to support global regulatory outcomes.
- Lead the Global Regulatory Affairs Strategy Team for assigned products, setting priorities, coordinating deliverables, assigning responsibilities, and aligning global regulatory functions.
- Act as primary Global Regulatory Affairs reviewer and, where appropriate, approver of development deliverables such as protocols, Target Product Profiles, and strategic documents; provide regulatory guidance to senior leaders and cross-functional teams.
- Oversee strategic regulatory documents and initiatives, including Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and Global Regulatory Strategy Outlines.
- Use competitive regulatory intelligence, emerging technologies, AI-enabled insights, business analytics, and specialized regulatory expertise to inform strategy and anticipate challenges.
- Build relationships across Global Regulatory Strategy, regional regulatory teams, and Regulatory CMC to promote alignment, consistency, and knowledge sharing.
- Where applicable, coach and develop Regional Regulatory Leads, establish performance expectations, foster accountability, and support succession planning and career growth.
- Demonstrate CSL leadership capabilities by building partnerships, thinking strategically, driving outcomes, embracing agility, inspiring innovation, and cultivating talent.
Benefits
- Incentive compensation and equity may be included in total compensation in addition to base salary.
- CSL provides benefits; the posting directs candidates to its benefits information page.
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What This Job Offers
Job Type
Full-time
Career Level
Director
