Associate Director, Regulatory Affairs
Posted on: November 22, 2021
Position Overview: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.Key Responsibilities:
- Ability to assess complex regulatory challenges and suggest
- Partner across Regions at a project level to ensure
transparency and alignment of global and regional regulatory
- 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
- 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.Basic Qualifications:
- 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
- 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
- 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.
- High standards of integrity.
- Demonstrated "Think out-of-the-box" mindset.
- 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.#GD-SA#LI-SAAt 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 , Associate Director, Regulatory Affairs, Executive , Cambridge, Massachusetts
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