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, Regulatory Therapeutic Area Lead is a member of the GRA GPS Leadership Team and contributes to the vision and goals for Global Regulatory Affairs (GRA) by:
Providing innovative scientific and regulatory vision, leadership and oversight in defining aligned global regulatory strategies for CSL Behring’s developmental portfolio and core regulatory support for products
without ongoing clinical development and accountable for clinical and safety content globally of CSL Behring regulatory documentation for an assigned therapeutic area. Leading and responsible for the activities in a GRA therapeutic area globally and overseeing associated direct reports (as
applicable) at CSL Behring’s global facilities, such as in the USA, Germany, Switzerland, Australia, and Japan. Assuring a productive collaboration with key internal therapeutic area stakeholders, such a early and late stage clinical development, commercial development, safety and project management leads, to
ensure successful development, strategic alignment and execution of global regulatory strategies that result in successful applications for CSL Behring’s product portfolio, from early development to Marketing Authorization (MA), and for any post MA submissions clinical line extensions.
In collaboration with GRA Regional leads, supporting the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies for CSL Behring’s
therapeutic areas. Lead the GRA Therapeutic Area Team with a focus on
collaboration and decision making for the therapeutic area with GRA functional
TA & Site Leads, as appropriate. Represents the GRA Therapeutic Area as a core member of the
R&D-wide Therapeutic Area Leadership Team.
QUALIFICATIONS / EXPERIENCE
A bachelor degree (four-year university 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 clinical foundation.
Minimum of 15 years’ experience in the biotech or
pharmaceutical industry, with at least 8 years (prefer 10 years) in Regulatory Affairs
Experience in leading and managing teams (Minimum 5 years), setting clear direction, holding people accountable and fostering a collaborative team environment.
Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan)
Experience working in Regulatory Affairs in a global
environment across two or more geographic areas (preferentially US and EU).
Extensive experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
Experience working in a complex and matrix environment is
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