Position Purpose:
The Director, Senior Global Regulatory Lead (Sr. GRL) in Global Regulatory Strategy (GRS) is a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as follows:
- 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: Bachelorās 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.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patientsā 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 worldās 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 ViforĀ 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.
Ā 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.