Position Purpose:
The Director, Senior Global Regulatory Lead (Sr. GRL) in Global Regulatory Strategy (GRS) is a member
- Develops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities
- Acts as a key member and single GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice
- Leads health authority interactions (FDA, EMA) and builds productive relationships to drive positive regulatory outcomes globally
- Engages GRAST members to deliver regulatory outputs, fosters accountability and collaboration, and serves as decision-maker/approver for regulatory deliverables. Ensures strong communication between regulatory and R&D teams
- For selected roles, manages Regional Regulatory Leads and supports their development and career growth
Main Responsibilities and Accountabilities
- Builds strong relationships with Product Strategy Teams, Clinical Development Teams, Safety Management Teams, and other stakeholders to ensure effective collaboration and communication
- Manages strategic relationships with key health authorities (FDA, EMA) and coordinates with regional leads for non-home country interactions
- Acts as the single GRA reviewer/approver for key deliverables and participates in regulatory due diligence and senior-level discussions
- Leads preparation of key regulatory documents and mentors GRAST members
- Utilizes regulatory intelligence, analytics, and cross-functional expertise to develop global regulatory strategies
- Promotes consistency, collaboration, and knowledge sharing across Global Regulatory Strategy teams
- Coaches team members (where applicable) to develop innovative solutions and ensure timely execution of regulatory strategies
- Applies CSL leadership capabilities and supports talent development, succession planning, and team empowerment
Position Qualifications and Experience Requirements
- Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science required. Advanced degree (MS, PhD, MD, DVM) or MBA preferred
- Minimum 10 years in biotech or pharmaceutical industry, including at least 8 years in regulatory affairs and 5 years with developmental products
- Experience leading teams (preferably 5 years), including decision-making and fostering collaboration
- Knowledge of product development and regulatory requirements across major regions (EU, US, Japan)
- Experience interacting directly with at least one health authority
- Experience working in a complex, matrix environment preferred
