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For Companies At a Glance
- Tasks: Shape the future of medicine by driving global regulatory strategies for innovative projects.
- Company: Join a leading global healthcare company dedicated to improving lives through science.
- Benefits: Enjoy competitive salary, health benefits, and generous parental leave.
- Why this job: Make a real impact in drug development while growing your career in a supportive environment.
- Qualifications: BS/BA in a scientific field; advanced degrees preferred with relevant regulatory experience.
- Other info: Diverse and inclusive workplace with endless opportunities for personal and professional growth.
The predicted salary is between 108000 - 156000 £ per year.
Location: Cambridge MA/ Morristown, NJ
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or global regulatory strategy for assigned projects, including Health Authority (HA) interactions. The RS provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
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:
- Enables the GRL by providing quality regulatory input and position to internal business partners, including but not limited to the clinical development teams, commercial and GRT for assigned projects.
- Contributes to the GRT for assigned projects in alignment with the team's one regulatory voice for providing strategic input on the Target Product Profile (TPP), business planning, governance and committees. May be requested to lead GRT meetings.
- Contributes to the development of the Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for lifecycle management of products.
- May serve as a regional/local regulatory lead and point of contact with HAs for projects/products in their remit, as needed.
- Accountable for developing the HA engagement and interaction plans for their assigned products, including the authoring of the briefing document focused on the strategy and scientific content, leading the team through meeting preparations and moderating the meeting itself for the projects in their remit.
- May lead HA meetings and preparations as designated.
- Leads submission team or regulatory sub-team to ensure NDA/BLA/MAA/Extensions filings meet the project timelines for product launch and is responsible for the development and update of the core global dossier/collaborates with regional lead where region-specific submissions are applicable.
- Leads the IND/CTA submission strategy to ensure preparation timelines meet the project timelines for clinical trial initiation.
- Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management utilizing the support and input of cross-functional team and/or alliance partners where relevant.
About You
Qualifications:
- 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) preferred.
- At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of relevant Regulatory Affairs experience (regional and global), in early and late stage, development of multiple modalities; experience within regulatory CMC not directly applicable.
- Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA meeting briefing documents and negotiating with a national/regional HA preferred.
- Experience on multidisciplinary matrixed project teams (e.g. clinical study team) preferred.
- Project leadership experience 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 recognises 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 programmes 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; colour; 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.
The salary range for this position is: $147,000.00 - $212,333.33. All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programmes. Additional benefits information can be found through the.
Regulatory Strategist in Cambridge employer: Sanofi
Contact Detail:
Sanofi Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Strategist in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their regulatory strategies and be ready to discuss how your experience aligns with their goals. Show them you’re not just another candidate!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and boost your confidence. The more comfortable you are, the better you'll perform when it counts.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take that extra step to engage with us directly.
We think you need these skills to ace Regulatory Strategist in Cambridge
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Regulatory Strategist role. Highlight your relevant experience in regulatory affairs and how it aligns with the job description. We want to see how your skills can help us shape the future of medicine!
Showcase Your Expertise: Don’t hold back on showcasing your regulatory expertise! Include specific examples of your past work, especially any experience with HA interactions or submission strategies. This will help us understand how you can contribute to our Global Regulatory Team.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use straightforward language and avoid jargon unless necessary. We appreciate a well-structured application that makes it easy for us to see your qualifications at a glance.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there!
How to prepare for a job interview at Sanofi
✨Know Your Regulatory Stuff
Make sure you brush up on your regulatory knowledge, especially around the preparation of (s)BLA/(s)NDA/MAA and INDs/CTAs. Familiarise yourself with the latest guidelines from health authorities, as this will show that you're not just knowledgeable but also proactive in staying updated.
✨Prepare for HA Interactions
Since you'll be leading Health Authority meetings, practice how to present your briefing documents clearly and confidently. Think about potential questions they might ask and prepare your responses. This will help you feel more at ease during the actual meeting.
✨Showcase Your Teamwork Skills
Highlight your experience working in multidisciplinary teams. Be ready to share specific examples of how you've collaborated with clinical development teams or other cross-functional groups. This will demonstrate your ability to work flexibly and effectively within a team setting.
✨Align with Company Values
Research the company’s mission and values, particularly their focus on improving lives through science. During the interview, express how your personal values align with theirs and how you can contribute to their goal of making miracles happen in healthcare.
