Global Regulatory Lead

CSL Plasma•Waltham, PA

9h•Hybrid

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 throughout the product lifecycle, from early development through registration and post-marketing activities. It represents Global Regulatory Affairs on Product Strategy Teams and other cross-functional development teams, integrating regulatory strategy into product decisions and aligning it with business objectives. The Sr. GRL builds relationships with global health authorities, particularly the FDA and EMA, and guides regulatory teams through complex development and approval pathways. The role leads the Global Regulatory Affairs Strategy Team for assigned products, oversees key regulatory deliverables, provides regulatory guidance to senior leaders and cross-functional teams, and uses regulatory intelligence and emerging technologies to inform strategy. Depending on the role, the Sr. GRL may also lead and develop Regional Regulatory Leads.

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.
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 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.
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.
Demonstrated team leadership experience, preferably 5 years of direct or matrix leadership, including setting strategic direction, driving accountability, and developing talent.
Strong clinical development or medical device expertise.

Responsibilities

Develop and lead integrated, science-based global regulatory strategies for assigned products across 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 regulatory outcomes across global markets.
Lead the Global Regulatory Affairs Strategy Team for assigned products by setting priorities, coordinating deliverables, assigning responsibilities, and aligning global regulatory functions.
Serve as the 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 leadership and cross-functional teams.
Oversee key 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 proactively address challenges.
Build relationships across Global Regulatory Strategy, including regional regulatory teams and Regulatory CMC, to promote consistency, knowledge sharing, and a unified global approach.
Where applicable, coach and develop Regional Regulatory Leads, set 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.