Global Regulatory Lead
Bridgewater, 新泽西州剑桥, 麻薩諸塞州 Permanent 发布日期 Jun. 14, 2024
Job title: Global Regulatory Lead
- Location: Bridgewater, NJ or Cambridge, MA
About the job:
Our 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.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
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 making final decisions on the regulatory success rates and mitigations on behalf of the GRT.
About you:
Experience
- At least 12+ 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
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.
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.
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.
#GD-SA
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#LI-Hybrid
追寻 发展。探索 菲凡。
进步需要我们每个人的参与——不论其背景、地域、或职业,我们都有一个共同的愿望:创造奇迹。你也可以成为其中的一员。我们不断追求变革,拥抱新思想,探索我们所能提供的一切机会。让我们一起追求进步。共同发现非凡。
在赛诺菲,不分种族、肤色、血统、宗教、性别、国籍、性取向、年龄、公民身份、婚姻状况、残疾或性别认同,我们为所有人提供平等的机会。
观看 “在赛诺菲的一天” ,并在官网 (sanofi.com) 上查看赛诺菲的多元化、公平与包容倡议!
在美国的职位
加入我们的美国团队。我们将为您提供专家指导和培训平台,从而帮助我们营造良好的企业文化。我们鼓励您以饱满的热情和充沛的精力投入到工作中,然后发挥自身能力推进药物和疫苗的研发,同时将研发到临床治疗的时间减半。
体验可能性
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我们的办公地点
我们的员工遍布60多个国家/地区。他们勠力同心,携手共创医疗健康领域的美好未来。无论您在哪里工作,我们的专家都会指导您推动职业发展,您也将能够运用先进的科学技术,取得意义非凡的重大突破。
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勇敢追梦,奔赴美好未来
想要改变自己的生活,乃至改变全球数百万人的生活,该怎么做?加入我们,开启职业新篇章,然后在我们的保驾护航中展翅高飞,并向优秀的人求教,为这份事业做出切实的贡献。
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您和我们相互依存,共同成长
我们精心打造薪酬体系,为您的身心健康、财务健康与社交健康提供全面保障。我们有着海纳百川的包容性团队文化,无论您在哪个岗位,都能展翅高飞。
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心怀梦想,成就一番事业
我们希望您以饱满的热情投入到自己的工作岗位中,给全球数百万人带来美好生活。您的职业发展道路由您自己来掌控。您只管制定目标,我们会提供充足的培训机会和支持,让您得偿所愿。
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Sustainable and Green
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我们的人与文化
我们是首个建立多元化、公平性和包容性(DE&I)委员会的制药企业。我们还建立了“菲常联盟”,为每位员工提供发声的平台。您的声音是我们建设未来道路的重要基石。
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我们的故事
我们关注每一个员工的声音。因为,我们的未来取决于所有员工的付出与努力。正因为他们的助力,我们才能追求远大的理想。
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为什么选择我们?
我们为您提供各种工具、支持和培训机会,帮助您实现自己的目标。我们也希望您充分发挥潜力,帮助我们实现目标:将新药研发到临床治疗的时间减半。
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