Global Regulatory Lead

Company: Sanofi
Location: Cambridge
Posted on: September 20, 2023

Job Description:

Our Team:Our Global Regulatory Team is involved in developing regulatory product strategies for the therapeutic area, leading regulatory efforts in the development stage and post marketing of drug products.Main responsibilities:The Global Regulatory Lead (GRL) is the fully accountable decision maker for the development & execution of creative, thoughtful, and robust global regulatory strategies for their products in Sanofi's diversified portfolio in order to meet corporate and business objectives.Decisions are made in alignment with the Therapeutic Area (TA) Head, Global Business Unit (GBU) Head and up to the Global Regulatory Affairs (GRA) Leadership Team (LT) as needed. The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).Additional Details: - Accountable for leading the development and execution of innovative and value-added global regulatory strategies and be 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 - The role will supervise, coach, and facilitate a feedback culture within the Global Regulatory Team (GRT) to develop team performance

• The GRL is expected to develop a team of Regulatory Strategists (RS) as appropriate--- The GRL is accountable for ensuring alignment and communication internally and externally as "one GRA voice" with TA Head, 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--- The GRL is the single GRA point of contact for the program and represents GRA at the GPT / GBT and internal governance committees--- The role is accountable for monitoring and interpreting the global regulatory environments and accountable to ensure that it leverages expertise in other parts of GRA (e.g., regional experts) in order toensure that most robust strategy possible and is accountable for determining any updates to the regulatory strategy accordingly--- Leads development of global HA interaction plan and strategy in collaboration with GRT. Is accountable for the communication of the key outcomes to senior management--- Advances the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned therapeutic area and projects in collaboration with the Regions.--- Accountable for regulatory assessment for Due Diligence activities as applicable through the partnership with Strategy and Business Optimization.About youKnowledge, Skills & Competencies: (Minimum required) - Leads and leverages talent to the advantage of the greater team, with curiosity and openness to diverse perspectives--- Proactively cultivates a safe environment that inspires creativity, innovation, and productivity--- Proactively accountable for creating a forward-looking vision for their team/direct reports, influences the environment that maximizing long-term potential by fostering trust and teamwork--- Demonstrates exceptional business acumen, strong leadership presence internally and externally, mastery level influence and persuasive negotiation skills--- Mastered scientific acuity applicable to multiple therapeutic areas--- Proven track record of strategic leadership and significant experience making complex decisions, taking thoughtful risks, and defending difficult positions--- Proven track record of developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products--- Proven track record and expert (recognized internally and externally) using advanced communication skills (oral and written) to build internal teams and lead complex negotiations with internal and external stakeholders--- Mastery level organizational navigation; self-motivated and proven track record of leading teams in a highly matrixed structure including sharing knowledge with relevant stakeholders to drive business objectives--- Strong sensitivity for a multicultural/multinational environment--- Proven leader of groups and teamsExperience & Education: (Minimum required) - 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--- 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--- 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--- Strategic regulatory leadership expertise with experience in developing and implementing successful regulatory strategy and with preparation of at least one (s)BLA, (s)NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional Health Authority within a major market (e.g., US, EU)--- Proven record of leading filings/registrations and obtaining regulatory action in major market(s)--- Project leadership experience--- Proven track record of developing successful teams and managing direct reports - Change management/ change enabler: embraces the challenges of a fast-changing environment--- Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunitiesPursue progress, discover extraordinaryBetter is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. ---At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Keywords: Sanofi, Cambridge , Global Regulatory Lead, Other , Cambridge, Massachusetts