Global Regulatory Lead

  • Location Netherland (Amsterdam), US (Bridgewater, NJ / Cambridge, MA)

  • 50% Remote working and 20% of travel expected

  • Job type: Permanent, Full Time

About the job

Our Team

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

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).

  • 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 make 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

Experience

  • 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

  • Proven track record of developing innovative regulatory strategies supporting the clinical development of drugs and/or innovative biologics products

  • Proven record of leading filing/registrations and obtaining regulatory action in major market(s)

Soft skills

  • Lead and leverage talent to the advantage of the greater team, with curiosity and openness to diverse perspectives

  • Proactively cultivate a safe environment that inspires creativity, innovation, and productivity

  • Proactively accountable for creating a forward-looking vision for your team/direct reports, influence the environment that maximizing long-term potential by fostering trust and teamwork

  • Demonstrate exceptional business acumen, strong leadership presence internally and externally, mastery level influence and persuasive negotiation skills

  • Master 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 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

  • Strong sensitivity for a multicultural/multinational environment

Education

  • 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

Pursue progress . Discover extraordinary .

Better 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.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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.