Regulatory expert

1 week ago

Bangalore, India Tredence Inc. Full time

We are seeking an experienced Life Sciences Subject Matter Expert (SME) with deep expertise across Commercial Analytics and R&D functions. This role will partner with clients to shape solution strategies, evangelize data-driven offerings, and drive innovation across the drug development and commercialization lifecycle. Commercial Analytics Strategy & Enablement Evangelize advanced analytics solutions in areas such as sales & marketing effectiveness, patient journey analytics, market access, pricing & reimbursement, and digital engagement. Guide biopharma and medtech clients on leveraging real-world data (RWD), claims, EMR, and patient registries to optimize brand performance and market share. Support forecasting, targeting, segmentation, and omnichannel analytics to maximize commercial impact. R&D & Clinical Development Insights Advise on applying AI/ML and advanced analytics in drug discovery, clinical trial design, site selection, patient recruitment, and safety monitoring. Promote solutions around clinical operations optimization, trial feasibility, and biomarker-driven development. Drive integration of RWD, clinical, genomic, and digital biomarker data to accelerate R&D decision-making. Data-Driven Innovation Partner with data engineers and analytics teams to design dashboards, predictive models, and GenAI/Agentic AI solutions supporting both commercial and R&D use cases. Shape innovative offerings for functions like medical affairs insights, pharmacovigilance automation, and evidence generation. Guide strategies for harmonizing structured and unstructured data (e.g., publications, trial protocols, regulatory submissions) for actionable insights. Regulatory, Compliance & Thought Leadership Stay current with global regulatory requirements (FDA, EMA, ICH, GxP, GDPR, etc.) and industry trends affecting both commercial and R&D domains. Contribute to whitepapers, industry forums, and client education sessions to position the organization as a leader in life sciences analytics. Monitor emerging trends in digital health, decentralized trials, and personalized medicine to inform solution innovation. Required Skills and Experience: ~8-10 years of experience in Life Sciences industry consulting, commercial analytics, or R&D strategy. ~ Strong understanding of pharma/biotech value chain, spanning R&D, clinical, regulatory, market access, and commercial operations. ~ Hands-on experience with healthcare data sources: claims, EHR, registries, RWD, RWE, genomics, clinical trial data.

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