Director, Sr. Global Regulatory Lead, Hematology Ta

vor 13 Stunden

Bern, Schweiz CSL Behring Vollzeit

**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:

- ** GRA** Representatives** **on Product/Project Strategy Teams (PSTs), key 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 Leader**s**, engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability and ‘team spirit’, drive alignment, mentor and cultivate talent of members, act as decision maker for Team as needed, 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, cross-functional education and influence Regulatory Intelligence/Policy) for the Team.

**Reporting Relationships**:Role that this position reports to: Therapeutic Area Lead, GRA GPS

**Main Responsibilities and Accountabilities**:

- Actively contributes and builds effective relationships, as a Full-Time GRA Member, for respective product portfolio teams (e.g., PST, CDT, SMT, Incubator Project) and articulating sound, regulatory input/perspective into product strategy.
- Effectively leading the product portfolio GRASTs, utilizing 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, as appropriate.
- 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.
- Leverage GRAST, competitive regulatory intelligence/informatics, business insights / analytics and other specialized regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.
- Applies 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**:

- Minimum 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**:

- Minimum of 12 years biotech/pharmaceutical industry, with 8 years regulatory experience, including 5 years in development.
- Direct agency interaction experience, preferably ICH regions, as well as 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****:

- Strong scientific and ethical foundation.
- Consistently applies Servant Leadership and Team Player principles to team environment, including leading without authority.
- Builds and works effectively across cultures, inclusive and seeks out 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.

**About CSL Behring**:
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.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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