Director, Sr. Global Regulatory Lead, Hematology TA

Position Purpose: The Dir., Sr. Global Regulatory Lead, Hematology TA, is a member of a GRA GPS Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:

• Regulatory leaders, who build development of better, scientifically sound, prospective, global regulatory strategies for product/s, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome.

• GRA Representatives on Product/Project Strategy Teams (PSTs), main Delivery Teams (e.g., Clinical Development Teams [CDTs], Safety Management Teams [SMTs], Evidence Access Strategy Team [EAST]), and internal governance meetings as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective product/s.

• GRAST Leaders, engage GRAST members to achieve regulatory deliverables (including assign tasks) while promoting individual accountability and 'team spirit', improve understanding, mentor and cultivate talent of members, act as decision maker for Team, assess and communicate regulatory outcomes, encourage review/discussion, and contribute to or approve project-related deliverables (e.g. GRSO, TPP, TPC, CCDS, Protocol, CTD clinically-related sections, education and influence Regulatory Intelligence/Policy) for the Team.

Reporting Relationships: Role that you will report to: Therapeutic Area Lead, GRA GPS

Main Responsibilities and Accountabilities:

• Contribute and build relationships, as a Full-Time GRA Member, for respective product portfolio teams (e.g., PST, CDT, SMT, Incubator Project) and explaining sound, regulatory input/perspective into product strategy.

• Lead the product portfolio GRASTs, using full GRAST membership and 'One GRA' voice, to prudently and expeditiously deliver global regulatory submissions throughout development, including partnering with respective Regulatory Project Manager to ensure on-time delivery.

• Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members.

• Facilitate reviews and be respective GRA reviewer signatory for CTD clinical/safety documentation (development/registration) as applicable.

• Partner with GRA Region in product portfolio health authority interactions globally and participate in overall product/clinical/safety related interactions for portfolio.

• Ensure bi-directional communication between product (e.g., PST/CDT) and GRA teams (GRAST/GRA TA Team) on product related activities (scientific/business/patient), including driving management communication for GRA activities.

• Use GRAST, regulatory intelligence/informatics, business analytics and other specialized regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.

• You apply the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself and supports team members in these capabilities.

Position Qualifications and Experience Requirements:

Education :

• 4-year university degree (or equivalent) in scientific field (e.g., biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree preferred (e.g. PhD, MS, MBA).

Experience :

• 12 years biotech/pharmaceutical industry, with 8 years regulatory experience, including 5 years in development.

• Direct agency interaction experience, preferably ICH regions, and exposure across multiple ICH health authorities.

• Team leadership experience, preferably 5 years as direct or matrix manager.

• Clinical (or Device/Combination Product) regulatory experience preferred.

• Exposure to market access activities is preferred.

Competencies :

• Scientific and ethical foundation.

• Apply Servant Leadership and Team Player principles to team environment, including.

• Strategic ability to assess product vision and apply regulatory lens to articulate regulatory assumptions, opportunities, and risks.

• Build and work across cultures, inclusive and look for alternative perspectives when assessing potential outcomes.

• Prior experience mentoring junior staff members in regulatory affairs.

• Fluent in English (written & verbal).

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.