Manager Regulatory Affairs- Advertising and Promotion
Company: Sanofi
Location: Cambridge
Posted on: June 23, 2022
Job Description:
Key Responsibilities:
- Represent GRA (US AdPromo) as a member of cross-functional
brand and portfolio team review committees (RC), providing
regulatory input into the review and approval of advertising,
promotion, disease-state, medical, market access, and press
materials. Submit materials on form FDA 2253 when applicable.
- Provides US AdPromo strategies and opinions for investigational
and marketing products to mitigate risk, provide advice and give
risk/benefit analysis to meet both short- and long-term growth
targets. Consults with senior management and provides input to the
Global organization when necessary.
- Contribute AdPromo expertise to the development of optimal FDA
labeling on original and supplemental New Drug Applications and/or
Biologics License Applications.
- Primary Liaison with OPDP/APLB and effectively manages
relationships with FDA contacts; establishes and maintains strong
collaborative relationships with Regulatory and other R&D
colleagues, as well as other functions (e.g., Legal, Medical,
Marketing, Communications and Compliance)
- Participate in the development, monitoring and updating of
standards and processes related to drug, device, and biologics
AdPromo regulations and guidances.Basic Qualifications:
- Education: Bachelor's degree from an accredited four-year
college or university (area of specialization: Life Sciences).
- Job-Related Experience: 1-5 years experience within
pharmaceutical and/or medical device Regulatory Affairs.
- Successful track record with ideally 1-5 years relevant
regulatory experience.
- Dealt effectively with cross-functional groups, which may
include Medical, Legal, Marketing, etc.Knowledge and Skills:
- Knowledge and understanding of complex medical and scientific
subject matter.
- Ability to work well within cross-functional teams.
- Can demonstrate solid oral communication and writing
skills.
- Understanding of the U.S. pharmaceutical market place, and
familiarity with medical terminology.
- Understands 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 solutions.
- Develops collaborative relationships to facilitate the
accomplishment of work goals.
- In conjunction with the Director, generates innovative
solutions in work situations, trying different and novel ways to
deal with work problems and opportunities.
- Shows ability to use appropriate interpersonal styles and
techniques to gain acceptance of ideas or plans.
- Can build networks to obtain cooperation.
- Unquestionable ethics, professional integrity and personal
values consistent with the Sanofi values.
- Is able to balance projects with day-to-day duties, ensuring
participation from other members of the department as needed.
- Is able to establish priorities and timelines to effectively
manage workload. Is able to multi-task well.
- Deals with people in an honest and forthright manner
representing information and data accurately.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.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 , Manager Regulatory Affairs- Advertising and Promotion, Executive , Cambridge, Massachusetts
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