Fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies.
Primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).
Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives and setting clear expectations for Global Regulatory Strategy.
Responsible for proactively contributing to the Target Product Profile (TPP) and ensuring competitive profiles in alignment with business objectives.
Supervise, coach, and facilitate feedback culture within the GRT to develop team performance.
Accountable for ensuring alignment and communication internally and externally as “one GRA voice” with TA, GBU Head and up to the GRA LT when needed.
Identify opportunities to support the team in identifying regulatory acceleration opportunities, take thoughtful risks, and accept challenges.
Monitor and interpret the global regulatory environments and ensure robust strategy by leveraging expertise in GRA (e.g. Regional experts).

BS/BA degree in a relevant scientific discipline required.
Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred
At least 8-10 years of relevant pharmaceutical/biotechnology experience
At least 6 years of relevant Regulatory Affairs experience (regionally and/or global), especially in the development phase, with oncology experience
Demonstrated expert regulatory strategic experience and understanding of the regulatory environment to develop regulatory strategies
Experience being accountable for developing and defending innovative regulatory strategies at Global Project Teams or equivalent forum
Previous experience in leading Health Authority interactions in major markets
Strategic regulatory leadership expertise with preparation of (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with Health Authority within a major market.
Experience leading filings/registrations and obtaining a regulatory action in major market(s)

Global Regulatory Lead

Key skills