Global Regulatory Affairs Lead

• Location: Amsterdam, the Netherlands

About the job

The Global Regulatory Affairs Lead (GRA) 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.

The GRL is the primary interface and key strategic GRA partner for the Global Project Team (GPT) and Global Brand Team (GBT).

Main responsibilities

• 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
• Is 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 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, 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
• Leads development of global HA interaction plan and strategy in collaboration with GRT

About you

Experience

• 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 8-10 years of relevant pharmaceutical/biotechnology experience, including at least 6 years of relevant Regulatory Affairs experience (regionally and global), in early and late stage development of multiple modalities; experience within regulatory CMC not directly applicable
• 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 (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)
• Scientific acuity applicable to multiple therapeutic areas

Soft skills

• Connects and leverages talent to the advantage of the greater team, with curiosity and openness to diverse perspectives
• Nurtures a safe environment that inspires creativity, innovation and productivity
• Is responsible for creating forward-looking vision, influences the environment that optimizes long-term potential by fostering trust and teamwork
• Demonstrates business acumen, leadership, recognized influence and persuasive negotiation skills
• Recognized strategic thinker with an ability to make complex decisions and willingness to defend difficult positions
• Highly effective communication skills, specifically excellent oral and written presentation skills
• Organizational understanding; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders
• Strong sensitivity for a multicultural/multinational environment

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave

Pursue