Morristown, NJ, United States of America
Onsite
Job title: Regulatory Strategy & Continuous Improvement - Platform Lead
Location: Morristown, NJ
About the job
As Regulatory Strategy & Continuous Improvement - Platform Lead within our R&D team, you will lead multiple interconnected initiatives involving diverse stakeholders across the organization, orchestrating multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes. You will establish and maintain global responsibilities across GRA CMC & GRA Device departments, build and manage cross-functional governance structures to facilitate decision-making, identify synergies between parallel projects to leverage shared resources, and establish metrics and KPIs to track progress and drive continuous improvement. Additionally, you will facilitate resolution of cross-project dependencies and conflicts, develop communication strategies to maintain visibility of project interdependencies, and synchronize change management processes across interconnected systems and procedures.
Your responsibilities will include driving transversal process-related activities and projects across the department, contributing to activities and ways of working harmonization/standardization, validating and updating worldwide CMC post-approval regulatory requirements databases, and representing GRA CMC and/or GRA Device departments in transversal working groups and for Quality & Performance topics. You will establish and promote best practices and sharing experiences, manage and facilitate information sharing across departments to ensure connectivity and alignment on critical CMC & Device topics, and contribute to inspection-readiness as applicable.
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main responsibilities
Lead multiple interconnected and non-interconnected initiatives involving diverse stakeholders across the organization.
Orchestrate multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes.
Establish and maintain global responsibilities across GRA CMC & GRA Device departments, ensuring alignment between project objectives and broader organizational strategy.
Build and manage cross-functional governance structures to facilitate decision-making across interconnected projects
Identify synergies between parallel projects to leverage shared resources, eliminate redundancies, and maximize efficiency.
Establish metrics and KPIs to track progress across the project portfolio and drive continuous improvement.
Faciliate resolution of cross-project dependencies and conflicts through effective negotiation and prioritization.
Develop communication strategies to maintain visibility of project interdependencies and ensure alignment across stakeholder groups.
Synchronize change management processes across interconnected systems and procedures.
Cover a global responsibility across GRA CMC & GRA Device departments on activities within his/her scope
Drive/Manage transversal process related activities and or projects across the department and deliver documents (e.g. quality documents, Functional Best practice guides, slide kits…) helping the end-users to apply defined processes and ways of working.
Contribute to activities / WoW harmonization/standardization by taking the following action(s)
Optimize & improve efficiency of change control process, and of process for management of CMC post-approval commitments
Contribute to inspection-readiness as applicable
Validate, update & consolidate worldwide CMC post-approval regulatory requirements database for CMC Post-approval changes & RenewalsRepresent GRA CMC and/or GRA Device departments in transversal working groups dedicated to tools/systems optimization, e.g., IDMP
Represent GRA CMC and/or GRA Devices departments for Quality & Performance topics (e.g., quality documents creation/updates, KPIs…).
Establish and promote best practices and sharing experiences, e.g., manage/facilitate sharing of information across GRA CMC and/or GRA Device departments to ensure connectivity and/or to align on practices and critical CMC & Device topics.
About you
Education
Bachelor’s degree in a scientific discipline, or
Advanced degree (Masters, PhD) in a science or health field is desirable
Experience
Minimum 4 years of CMC and/or Devices regulatory experience. Additional 1-5 years of country/region-specific regulatory expertise is desirable.
Experience in project management is required.
Experience working for a Regulatory Authority, Quality Department, manufacturing site, project management/direction is preferred but not essential.
Soft skills
Experience working in a matrix environment and excellent people skills are required.
Previous experience working in a fast-paced environment on multiple project lines is highly desirable.
Ability to work transversally and to assume leadership of transversal topics/projects
Strong organization skills
Should demonstrate flexibility, proactivity, initiative, assertiveness & be able to communicate efficiently with various stakeholders internally and externally.
Potential to be able to mentor and train staff is desirable but not essential.
Technical skills
Knowledge of worldwide Health Authorities regulations, of key Health Authorities thinking (guidance/requirements/feedback), and regulatory trends.
Strong background in project management and understanding of drug development, manufacture, or testing.
Familiarity with combination (drug / device) products is preferred.
Proficient in MS Word, Excel, PowerPoint
Demonstrated ability to work successfully on global project teams.
Languages
Fluent in English both spoken and written
Why Choose Us
Bring the miracles of science to life alongside a supportive, futurefocused 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.
Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
Help improve the lives of millions of people globally by making drug development quicker and more effective.
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.
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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, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
North America Applicants Only
The salary range for this position is:
$148,500.00 - $214,500.00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.