Director, Global Reg Affairs-Oncology
Are you passionate about Oncology? Are you a regulatory affairs professional looking for a new and exciting opportunity in a growing organization? GSK Oncology is one of GSK Pharma's 4 core therapy areas and is considered a future growth driver for the company. Since 2014, GSK has progressed an innovative portfolio and has delivered multiple novel assets into clinical development (alone or in partnership).
GSK Global Regulatory Affairs is seeking candidates with strong regulatory affairs and oncology experience to join as Senior Director to work on products in three cutting edge areas of science: Immuno-oncology (IO), Oncology Cell Therapy (OCT), and Cancer Epigenetics (CE).
• In IO, anti-BCMA antibody-drug conjugate has demonstrated unprecedented efficacy (~60% overall response rate) in refractory/relapsed multiple myeloma, and has been granted Breakthrough Designation (BTD) and PRIME status by FDA and EMA, respectively. Other IO assets include the first-in-class anti-ICOS agonist antibody, anti-OX-40 agonist antibody, TLR4 agonist, and multiple near clinical stage assets.
• In OCT, GSK recently exercised the early opt-in option for an investigational NY-ESO-1 TCR-modified T cell therapy from AdaptImmune, also granted BTD and PRIME.
• The CE clinical pipeline includes multiple clinical stage assets including BET and PRMT5 inhibitors.
Global Regulatory Affairs (GRA)
Our Global Regulatory Affairs organization plays a critical role in enabling delivery of innovative products to patients. The integrated Global Regulatory Affairs team is focused on driving innovative global regulatory strategies that maximize the value of the R&D pipeline. We also operate a continuous learning organization that recognizes the importance of proactive efforts to shape the evolving regulatory environment in order to enable novel regulatory pathways for our portfolio of medicines.
The Role - Director, Global Regulatory Affairs, Oncology
The Director, GRA, serves as an empowered Global Regulatory Lead and/or Regional Lead for assigned assets. This role serves as a key strategic partner with the development and commercialization teams and works closely with the broader regulatory matrix team to conceive and deliver innovative regulatory strategies for assigned assets. In doing so, the Senior Director must be able to integrate aspects of strategic and operational regulatory affairs into asset development collaborating with the cross functional team including clinical research, biostatistics, nonclinical, CMC, diagnostics/device, etc. This role is responsible for leading preparations and delivery of Health Authority interactions and marketing authorizations with the cross functional development and regulatory team. In addition, they must proactively counsel and interpret health authority feedback, regulatory precedent, guidelines and policy to drive the product strategy, as well as driving or supporting efforts to shape the regulatory environment.
Bachelors or advanced degree in appropriate scientific discipline
Demonstrated leadership capabilities and ability to think strategically. Extensive regulatory experience in drug development and life-cycle management
Prior experience leading health authority interactions; and experience leading or supporting major submissions from filing through approval.
Ability to integrate regulatory science with scientific/clinical knowledge.
Demonstrated track record of working in a global team and matrix organization
Strong written and verbal communications skills
Excellent negotiation skills across levels within an organization and with external stakeholders
Able to manage multiple projects and proactively plan.
Master's Degree or PhD (or equivalent)
Global regulatory experience
Experience in companion diagnostic and device
Experience in working with strategic partners/cross company collaborations
Experience in partnering with business development in due diligence efforts
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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