Global Regulatory Lead

Global Regulatory Lead

Sanofi

Amsterdam, Netherlands

About the job

As Global Regulatory Affairs Lead (GRL), you will be the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for your products in Sanofi’s diversified portfolio in order to meet corporate and business objectives. You will be the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT). The team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products.

Main responsibilities

  • Accountable for leading the development and execution of innovative and value-added global regulatory strategies and responsible for formulating the Global Regulatory Project Strategy (GRPS), Global Submission Strategy, and core product labeling in development as well as for life cycle management of products;
  • Responsible for proactively contributing to the Target Product Profile (TPP), ensuring competitive profiles in alignment with the business objectives;
  • Accountable for leading the GRT for fostering team performance by aligning team on mission, prioritization, objectives and setting clear expectations for the Global Regulatory Strategy and Plan, including a global labeling strategy for assigned projects;
  • Supervise, coach, and facilitate a feedback culture within the GRT to develop team performance;
  • Develop a team of Regulatory Strategists (RS) as appropriate;
  • 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 to advocate regulatory position to governance and committees and shares outcomes to GRT and cross-functional partners as appropriate;
  • Identify opportunities to support the team to identify regulatory acceleration opportunities, take thoughtful risks, accept challenges, and making final decisions on the regulatory success rates and mitigations on behalf of the GRT;
  • Lead development of global HA interaction plan and strategy in collaboration with GRT.

About you

  • At least 12-15 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global), in early and late development;
  • Proven record of leading filing/registrations and obtaining regulatory action in major market(s);
  • 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;
  • Proven track record of developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products;
  • Lead and leverage talent to the advantage of the greater team, with curiosity and openness to diverse perspectives;
  • Demonstrate exceptional business acumen, strong leadership presence internally and externally, mastery level influence and persuasive negotiation skills;
  • Proven track record of strategic leadership and significant experience making complex decisions, taking thoughtful risks, and defending difficult positions;
  • Proven track record and expert (recognized internally and externally) using advanced communication skills (oral and written) to build internal matrix teams and lead complex negotiations with internal and external stakeholders;
  • 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.

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