Associate Director, US Regulatory Lead
Posted on: November 23, 2021
The role is primarily responsible to develop innovative, robust US
regulatory strategies and ensure their efficient and effective
execution for life-cycle assets in clinical development for
assigned therapeutic area which adhere to US regulatory and company
guidelines with minimal oversight. 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. Further, the
role represents the NA GRA perspective as a member of project
specific cross functional global regulatory team (GRT) and is
accountable to develop and maintain US aspects of regulatory
strategy documents. 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. Lastly, 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.
Strategic & Technical Regulatory Affairs Expertise:
Familiarity with complex medical and scientific subject matter as
well as evolving US regulatory policy and guidance.
Developing strategic skills including the ability to make complex
decisions and willingness to defend difficult positions with
oversight from Management.
Practical experience with preparation of initial BLA, NDA, or INDs,
Health Authority meeting briefing documents.
Knowledge 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.
Ability to flex interpersonal styles and techniques and can modify
behavior to gain acceptance of ideas or plans.
Excellent oral communication, writing and presentation skills with
Some direct interaction/negotiation experience with US FDA.
Ability to work well within cross-functional globally oriented
Knowledge and Skills:
Excellent operational skills including planning, organizing and
ability to motivate and lead others.
Ability to work in electronic document management system.
A working understanding of the U.S. pharmaceutical marketplace and
familiarity with medical terminology.
Ability to identify issues, problems, and opportunities by
comparing data from different sources to draw conclusions.
Ability to build networks to obtain cooperation without relying on
High standards of integrity.
Strong interpersonal skills.
Dedicated and persuasive -can-do - attitude.
Independently motivated, detail oriented and good problem-solving
Self-motivated; entrepreneurial spirit; excellent time management
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 5-8 years' experience in drug development.
Working knowledge of drug development process and US regulatory
Direct experience developing and implementing regulatory strategies
for US INDs, BLA, and/or NDAs.
Experience with drug development in the therapeutic area.
Some experience operating in a global environment.
Advanced scientific degree preferred. B.A./B.S. or higher degree
(s) in the sciences, or health related field.
Regulatory Certification (RAC) (optional).
Fl uent 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
Keywords: Sanofi, Trenton , Associate Director, US Regulatory Lead, Executive , Bridgewater, New Jersey
Didn't find what you're looking for? Search again!