Head of Gra Regions

vor 13 Stunden

Bern, Schweiz CSL Behring Vollzeit

Position Summary:
- The Head of GRA Regions is a key leadership position for providing strategic guidance and leadership for affiliates and managerial oversight of the Global Regulatory Affairs Regional teams. The role manages and leads a global team of Regional regulatory cluster regulatory professionals who support CSL Group's regulatory business objectives across Europe (EU, CH and UK), Middle East and Afrika (MEA), APAC, Intercontinental, LATAM and North Americas. The Head of GRA Regions is a member of the Global Regulatory Affairs Leadership Team (GRALT) and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Driving and executing comprehensive, commercially and globally aligned regulatory activities across all regions for CSL Group's future product portfolio (incl. Vx) throughout development and after commercialization. Accountable for CSL Group's relationship with respective Health Authorities globally.

Providing high level strategic regulatory direction, leading the global regulatory perspective and aligning regional strategies to contribute to the global regulatory strategy and risk assessments throughout the product lifecycle for CSL Group's future product portfolio (incl. Vaccines).

Overseeing regional/country regulatory representation at trade associations to provide business relevant input towards and awareness of new legislation and changes in the regulatory landscape.

Developing Policy Roadmap and Regulatory Intelligence in close collaboration with the Global Regulatory Science and Policy Team to account for changes in relevant regulations / laws impacting CSL Group's business globally. Assessing these changes for impact to the business and CSL Group's product portfolio.

Coordination, aligning, developing and leading the establishment and maintenance of high-quality relationships with Health Authorities and collaborating with Head of GRA GPS & GRA CMC to enhance these relationships.

Leading and overseeing GRA Regional Regulatory Teams.

Contributing as a member of GRA leadership meeting (GRALT), leading the GRA Regional Leadership Team within the GRA organization.

Collaborating and aligning with GRA functional heads, as appropriate, including exchanging information on relevant topics.

Qualifications & Experience Required:

- Minimum of 15 years’ experience Regulatory (with 5+ years of that time in a commercial stage organization) with a proven track record of significant regulatory accomplishments
- Up to date knowledge of regulatory environment; thorough understanding of the complex set of regulations within which the organization operates and awareness of the subtleties of regulations worldwide.
- Up to date knowledge and appreciation of the science driving drug discovery & development processes and product lifecycles.
- Demonstrated ability to make compelling scientific and/or strategic arguments to support all regulatory aspects related to the therapeutic/disease area.
- Ability to read, interpret, evaluate and disseminate regulatory guidance and policy to ensure regulatory compliance, including ability to analyze impact on CSL Group's strategic direction and operations.
- Experience of working with external stakeholder bodies, e.g. trade associations.
- Experience in leading and managing teams (minimum 10 years).
- Experience in leading negotiations and facilitating resolution of issues with regulatory agencies, with positive outcomes.
- Experience working in a complex and matrix environment is required
- Demonstrated experience in working with multiple stakeholders.

**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.

**Do work that matters at CSL Behring**:

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