Requires previous experience as a GRL and USRL. Expertise in supplemental submissions, responding to HAs, post-marketing requirement (PMR) study negotiations, labeling negotiations – a plus.
Ability to develop and lead global and US regulatory activities, including creating regulatory strategies, providing regulatory advice, and assessing risk, and driving HA interactions (written or live). Expectation is having established knowledge of US regulations and USRL role, as well as understanding general implications to properly engage global regulatory team (GRT) on strategy.
Ability to effectively collaborate with teams (cross-functional at GPT, and leading regulatory function at GRT), being able to identify issues, problem-solve at a GPT-level and gather appropriate information from GRT to align on a regulatory assessment/recommendation.
Ability to effectively communicate within teams and leadership, e.G., to explain complex issues to obtain alignment.
Communication
Ability to identify and work with urgency
Nice to have: Earlier experience as changes in BoW sometimes occur.
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📌 Global Regulatory Lead- (Global & Us Regulations) (Madrid)
🏢 VBeyond
📍 Madrid