Europe Regulatory Strategist

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Represent a particular region for regulatory sciences (US, EU or EM).
Provide regional strategic expertise as a member of the Global Regulatory Strategic Team (GRST).
Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
Be accountable for timely submissions and approvals with commercially attractive labelling in the designated region.
Be accountable for ensuring optimal regulatory interactions with Health Authorities, in relation to the assigned project(s) within the designated region.
Be accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
Ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post-filing activities.
Partner with project teams and other customer groups to ensure required regulatory contributions (line plans, label, CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
Ensure regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
Ensure an aligned regional regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.
Engage in appropriate activities in order to influence the regional regulatory environment through OGRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
Ensure business compliance and implementation of and adherence to Regulatory standards.
Develop and maintain, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.

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Europe Regulatory Strategist | JobCheckPoint

Europe Regulatory Strategist

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