It began with a promise. CSL Behring's parent company, CSL, was formed more than 100 years ago to save lives using the latest technologies. In the century since, CSL Behring has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. Our ability to innovate and deliver life-saving medicines for patients with rare disease and other unmet medical needs around the world has earned us a reputation for always putting patients first. We are CSL Behring and we are driven by our promise.
The Senior Director, GRA North America Region leads regional regulatory professionals who support CSL Behring’s regulatory business objectives in the USA and Canada.
The Head of GRA Region North America 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 within North America for CSL Behring’s product portfolio throughout development and after commercialization and is accountable for CSL Behring’s relationship with respective health authorities within the North American region.
- Providing high level strategic US regulatory direction, leading the North American regional regulatory perspective and aligns with other regional strategies to contribute to the global regulatory strategy and risk assessments throughout the product lifecycle for CSL Behring’s product portfolio.
- Leading and overseeing regulatory representation at North American trade associations to provide business relevant input towards and awareness of new legislation and changes in the regulatory landscape and exchanges information with GRA Regulatory Intelligence and Policy, as appropriate.
- Developing North American Policy roadmap and regulatory intelligence with close collaboration with Global Regulatory Intelligence and Policy team to account for changes in relevant regulations / laws impacting CSL Behring’s business within USA & Canada and assesses these changes for impact to the business and CSL Behring’s product portfolio.
- Developing and leading the establishment and maintenance of high quality relationships with the US Food & Drug Administration (FDA) and collaborates with Head of GRA GPS & GRA CMC to enhance this relationships. The Head of GRA Region North America is the primary CSL Behring representative to this health authorities and supports further relationship building at the national level within Canada.
- Leading and overseeing GRA Region North America regulatory team in King of Prussia.
- Assuring a productive collaboration with key internal stakeholders, such as North American commercial operations and affiliate regulatory affairs, to ensure successful development, strategic alignment and execution of regional regulatory strategies that result in successful applications for CSL Behring’s product portfolio, from early development to approval, and for any post-approval submissions.
- Contributes as a member of GRA leadership meeting (GRALT), GRA Region NA Leadership Team, and Strategy Mapping Regulatory Team meetings (SMRT) within the GRA organization
- Collaborating and aligning with GRA functional heads, as appropriate, including exchanging information on relevant topics.
- Acting as the Regulatory Site Head (GRA community leader for all GRA staff located at a CSL Behring site), depending on where the incumbent is located and other GRALT members co-located in same site.
Education and Qualifications:
A science degree (four-year degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required. An advanced degree in a related field is preferred (MS, PhD or MD, DVM).
Ideal candidates will have a strong USA regulatory foundation.
- Minimum of 15 years’ experience in the biotech or pharmaceutical industry, with at least 10 years in 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 the US 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 CSLB strategic direction and operations.
- Experience of working with external stakeholder bodies, e.g. trade associations.
- Experience in leading and managing teams (Minimum 5 years).
- Candidates must have thorough knowledge and understanding of US regulatory environment, specifically working with the US FDA is critical, and experience with Canadian procedures.
- Experience in leading negotiations and facilitating resolution of issues with regulatory agencies, of interest USA FDA, with positive outcomes.
- Experience working in a complex and matrix environment is required
- Demonstrated experience in working with multiple stakeholders.
About this company
CSL Behring is a global biotechnology leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 25,000 people, and delivers its life-saving therapies to people in more than 60 countries.
Location/Region: King of Prussia, PA