Director, Regulatory Affairs, North America
Company: Sanofi
Location: Cambridge
Posted on: July 30, 2022
Job Description:
JOB DESCRIPTION:The US Regulatory Affairs Lead is responsible
for the proactive development of innovative and robust US
regulatory strategies for pipeline and lifecycle assets in Sanofi's
Rare Disease & Rare Blood Disorders portfolio.He/she will be
accountable for the efficient and effective execution of US
regulatory strategies while adhering to US regulatory and company
guidelines. The US RA Lead will serve as Sanofi's liaison to the US
FDA for assignedrare disease projects in clinical development,
which may include small molecules, biologics and gene therapy
programs. In this role, he/she will lead the strategic development
of documentation submitted to the US FDAand lead FDA meetings and
negotiations. Further, the role represents the US GRA perspective
as a member of the project specific cross functional global
regulatory team (GRT). In this capacity, he/she will be accountable
todevelop and maintain the US regulatory strategy documents and
advise on US regulatory issues at internal governance meetings. In
addition, the role prospectively works with the labeling strategist
and the GRT todevelop 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 andproducts. 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 will coach andmentor
junior staff supporting the 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
skillsOther 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" mindsetEXPERIENCE:
- At least 8 years experience in Regulatory Affairs strategy
- 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 field of rare disease
or gene therapy is preferred
- 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 desirableAt
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.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-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 , Director, Regulatory Affairs, North America, Executive , Cambridge, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...