Director, Global Regulatory Affairs Strategy
Company: Sanofi
Location: Cambridge
Posted on: June 22, 2022
Job Description:
Job Highlights:
- The Global Regulatory Affairs Lead (GRTL) Immunology &
Inflammation will be responsible for leading the Global Regulatory
Team (GRT) in the development of innovative and creative global
regulatory strategies for pipeline and lifecycle assets in Sanofi's
growing and diversified Immunology & Inflammation 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 corporate governance meetings for assigned
projects.
- In this role, the person will be accountable to lead the GRT
and collaboratively develop and maintain the Global Regulatory
Strategy and Plan, including a global labeling strategy for
assigned projects.
- 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 role may be assigned direct reports.
Basic Qualifications:
- BS/BA degree in a relevant scientific discipline required.
Advanced degree is preferred (MS/MA/PharmD/Ph.D./ MD)
- At least 6 years relevant experience in regulatory affairs
(regionally and/or global) including 8 years relevant
pharmaceutical/biotechnology industry experience.Preferred
Qualifications:
- Demonstrated strategic thinker with an ability to make complex
decisions and willingness to defend difficult positions
- Demonstrated leadership experience with preparation of
(s)BLA/(s)NDA/ MAA, INDs/CTAs, Health Authority meeting briefing
documents and negotiating with a national/regional health
authority.
- Demonstrated understanding of clinical development of drugs
and/or innovative biologics products.
- Effective communication skills, specifically excellent oral and
written presentation skills
- Excellent time-management and operational skills including
planning, organizing and experience to effectively motivate and
lead others.
- Experience working in electronic document management systems,
e.g. Veeva vault
- Organizational savvy; self-motivated and able to work in a
highly matrixed structure including sharing knowledge with relevant
stakeholders
- Experience mentoring/coaching junior staff
- Understanding of the global Immunology & Inflammation
pharmaceutical marketplace, and drug development
- Strong sensitivity for a multicultural/multinational
environment.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.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.As a healthcare company and a
vaccine manufacturer, Sanofi has an important responsibility to
protect individual and public health. All US based roles require
individuals to be fully vaccinated against COVID-19 as part of your
job responsibilities.Fully vaccinated, according to the CDC, an
individual is considered to be "fully vaccinated" fourteen (14)
days after receiving (a) the second dose of the Moderna or Pfizer
vaccine, or (b) the single dose of the J&J vaccine. Fully
vaccinated, for new Sanofi employees, is to be fully vaccinated 14
DAYS PRIOR TO START DATE.#GD-SG
#LI-GZAt 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.
Keywords: Sanofi, Cambridge , Director, Global Regulatory Affairs Strategy, Executive , Cambridge, Massachusetts
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