The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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The Senior Director, Oncology Global Regulatory Affairs is part of the Specialty Care Global Regulatory Affairs (GRA) team. The Senior Director will be primarily responsible for the development of global regulatory strategy to advance the assigned portfolio of development pipeline candidates and life cycle management of marketed products. Reporting to the Oncology Therapeutic Head of Regulatory Affairs, this individual will work in a “player/coach” model to provide strategic input directly for assigned projects and oversight of a team of Global Regulatory Team Leads (GRTLs). The position may be based in the US at either Sanofi’s Bridgewater, NJ or Cambridge, MA sites or in Amsterdam, Netherlands.
Responsible to mentor and manage a small team of Global Regulatory Affairs Team Leads (GRTLs).
Serve on the Global Regulatory Oncology Leadership Team.
Partner across Regions at a portfolio level to ensure transparency and alignment of global and regional regulatory strategy.
Strong working knowledge of the global regulatory environment.
Function as a player/coach to develop regulatory strategies for assigned projects.
Responsible to proactively develop innovative, robust global regulatory strategies for pipeline and lifecycle assets in clinical development 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.
Demonstrated ability to work transversally to ensure global regulatory sub-teams function effectively, including but not limited to the development and maintenance of global strategy documents addressing regulatory risks and mitigations, global submission strategies, and reimbursement strategies.
Represent Regulatory’s position at internal governance meetings within function and/or broadly with R & D Senior Leadership.
Provides regulatory due diligence assessments of new business opportunities, as required.
Ensure compliance with all regulatory and internal Sanofi policies.
BS degree in a relevant scientific discipline required. Advanced degree is preferred (MS/PharmD/Ph.D./ MD).
At least 15 years industry experience, with at least 10 years’ experience in regulatory affairs (regionally and/or global).
Strategic lead experience for a major regulatory application (MAA/NDA/BLA/JNDA/etc).
Solid working knowledge of drug and/or biologic development process.
Prior experience in the oncology therapeutic area.
Prior experience in managing and developing internal talent.
Knowledge, Skills and Other Experience:
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving global regulatory environment.
Strategic thinker with an ability to make complex decisions and willingness to defend difficult positions.
Ability to generate innovative 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.
Understanding of the clinical development of drugs and/or innovative 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 build internal networks and lead negotiations with internal and external stakeholders.
Excellent oral and written presentation skills.
Ability to work well within cross-functional globally oriented teams.
Excellent time-management and operational skills including planning, organizing and ability to motivate and lead others.
Ability to work in electronic document management systems.
High standards of integrity.
Organizational savvy; self-motivated and able to work in a highly matrixed structure including sharing knowledge with relevant stakeholders.
A demonstrated "Think out of the box" mindset.
Demonstrated understanding of the global oncology pharmaceutical marketplace.
Strong sensitivity for a multicultural/multinational environment.
As Sanofi is expanding its capabilities in regenerative medicines, such as gene and cell therapy, prior experience in this area is especially welcome.
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.
Internal Number: R2590718
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