Director, Regulatory Affairs, North America
Cambridge, Massachusetts, Bridgewater, New Jersey
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The role is primarily responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for assigned therapeutic area which adhere to US regulatory and company guidelines.In addition, the role represents Sanofi to the US FDA for assigned projects and leads the strategic development of documentation submitted to the US FDA and leads FDA meetings. Further, the role represents the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents and for US regulatory issues at internal governance meetings. In addition, the role prospectively works with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information. The role works with and participates on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products. The role participates in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations. Lastly, the role may supervise, and/or coach mentor, junior staff supporting regulatory team.
Competencies For Success:
Strategic & Technical Regulatory Affairs Expertise:
- Strategic thinker
- Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
- Demonstrated experience with preparation of initial BLA, NDA, or MAA, INDs, Health Authority meeting briefing documents
- Understanding of the development of drugs and/or innovative biologics products. Experience in orphan drugs a plus
Communication & Influencing:
- Develops collaborative relationships to facilitate the accomplishment of work goals
- Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
- Excellent oral and written presentation skills
- Direct interaction/negotiation experience with US FDA
- Ability to work well within cross-functional globally oriented teams
- Demonstrates excellent oral communication and writing skills
Other Personal Characteristics:
- Excellent operational skills including planning, organizing and ability to motivate and lead others
- Ability to work in electronic document management system
- Thorough understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology
- Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
- Ability build transversal networks to obtain cooperation without relying on authority
- High standards of integrity
- Strong interpersonal skills
- Dedicated and persuasive “can-do” attitude
- Independently motivated, detail oriented and good problem solving ability
- Self-motivated; entrepreneurial spirit; excellent time management skills
- Organizational savvy; be able to work in a highly matrix structure including sharing knowledge with relevant stakeholders
- “Think out of the box” mindset
- At least 10 years' experience in drug development
- Solid working knowledge of drug development process and US regulatory requirements
- Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs
- Experience with drug development in the therapeutic area
- Demonstrated experience successfully operating in a global environment
- Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field, minimum 8 years regulatory strategy experience
- Regulatory Certification (RAC) (optional)
- Fluent English required; additional languages desirable
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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