Manager, Regional Regulatory Strategist
1 week ago
JOB SUMMARYThe purpose of this role is to:Represent a particular region for regulatory affairs (US, EU or EM).Provide regional strategic expertise to relevant forums (i.e., to the GMT, Global Regulatory Strategic Team (GRST), etc.).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 as the main point of contact with Health Authorities in relation to the assigned project(s) within designated region.Role can be combined with other Regulatory Role(s) (i.e., Global Regulatory Lead).Provide operational support of activities as assigned (i.e., researching regulatory background for products in scope).JOB RESPONSIBILITIES Accountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for assigned projects.Ensures regulatory contributions achieve the objectives in the strategy, to agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.Partners with project teams and other customer groups (e.g., RU/BU, Regional Commercial Teams) 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.Ensures regulatory plans are monitored, progress/variance is communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) are mitigated.Ensures 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.Engages in appropriate activities to influence the regional regulatory environment through GRS-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.Ensures business compliance and implementation of and adherence to Regulatory standards. Develops and maintains, directly or indirectly, constructive working relationships with Health Authority contacts in the assigned region.Maintenance of information in regulatory systems and support of regulatory systems incl. data analysis and mining.Support of operational activities as assigned including coordination of submissions, responses to regulatory queries, labeling activities, market requirements management, and other regulatory tasks.Support creation and maintenance of documents like internal trackers and submission documents incl. QC and gap analysis.Provide regular updates on work progress, highlighting any critical developments or emerging risks that may impact outcomes or require leadership attention.QUALIFICATIONS / SKILLSEducation/Experience: BS/BA (Pharmacy, Chemistry, Biology, or related science) with 5+ years of related technical experience or MS with 3+ years related technical experience or PhD with
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