Associate Director, Regulatory Affairs
Cambridge, Massachusetts, Bridgewater, New Jersey
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At Sanofi R&D North America, we deliver meaningful solutions for patients. We transform science into breakthrough, best-in-class and first-in-class medicines and vaccines. We believe in creating a diverse and inclusive workforce – and workplace – which brings together the collective brainpower of over 2,000 colleagues and provides you with an exciting place to grow and develop. We set the bar high, and we deliver. Join us and together we will build on our trusted legacy of breakthroughs for society.
This is an exciting time to join the team focused on Oncology. Hear from our Clinical Development leaders, Peter Adamson and Dietmar Berger, on our Oncology pipeline. You can also learn more from our 2021 investor presentation focused on Oncology.
The Global Regulatory Affairs Lead (GRTL) for Oncology is responsible lead the Global Regulatory Team (GRT) in the development of creative and thorough global regulatory strategies for pipeline and lifecycle assets in Sanofi’s growing and diversified oncology portfolio. The person will serve as Sanofi’s liaison to internal business partners including but not limited to the Global Project Team and represent regulatory at Governance meetings for assigned projects. In this role, the person will be accountable to develop and maintain the Global Regulatory Strategy and Plan for assigned projects in collaboration with the GRT. In addition, the role prospectively works with members of the GRT to ensure a cohesive global regulatory and labeling strategy. The role works with and participates on multi-disciplinary matrixed project teams to effectively meet project deliverables while adhering to regulatory requirements for programs and products. The role participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations. The position is based in the US.
Ability to assess complex regulatory challenges and suggest solutions.
Partner across Regions at a project level to ensure transparency and alignment of global and regional regulatory plan.
To effectively work in a highly matrixed organization to proactively develop and document creative, thorough global regulatory strategies for pipeline and lifecycle assets in clinical development addressing regulatory risks and mitigations, global submission strategies, and reimbursement strategies through collaborative partnership and leadership of Global Regulatory Teams.
Function as a strategic partner for cross-functional Global Product Teams (GPTs) to develop differentiated products with optimized labeling. In this capacity, the role will serve as the single point of contact for the business and R&D on regulatory issues for assigned projects.
Ensure timely communications of relevant topics to the business and up through GRA Senior Management.
Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
Bachelor's degree and at least 6.5 years in Regulatory Affairs or relevant industry experience.
Master’s, PharmD, PhD degree and at least 4.5 years in Regulatory Affairs or relevant industry experience.
Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
Knowledge, Skills and Other Experience:
Strategic thinker with the ability to generate creative solutions to complex problems, identifying different and novel ways to find solutions.
Demonstrated experience with preparation of initial BLA, NDA, or MAA, INDs, Health Authority meeting briefing documents and negotiating with a national/regional health authority.
Demonstrated understanding of clinical development of drugs and/or novel biologics products.
Demonstrated ability to develop collaborative relationships to facilitate the accomplishment of work goals.
Demonstrated ability to use appropriate interpersonal styles and techniques to develop internal networks and lead negotiations with internal and external stakeholders.
Effective communication skills, specifically excellent oral and written presentation skills.
Ability to work well within cross-functional globally oriented teams.
Excellent organization and operational skills including planning, organizing and ability to motivate and lead others.
Ability to work in electronic document management systems, e.g. Veeva vault.
High standards of integrity.
Demonstrated "Think out-of-the-box" mindset.
Strong sensitivity for a multicultural/multinational environment.
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.
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.
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