Associate Director, US Advertising and Promotion, Global Regulatory Affairs
Company: Sanofi
Location: Cambridge
Posted on: April 19, 2024
Job Description:
About the RoleThe Associate Director, US Regulatory Affairs (RA)
serves as the regulatory lead on relative Review Committees (RCs),
for products in the Rare Disease, Rare Blood Disorder and Neurology
portfolio. As the RC RA representative, work with brands on
competitively positioning assigned products appropriately while
maintaining compliance with applicable FDA regulations and company
policies for the advertising and promotion of prescription drugs
and biologics. Essential Functions - - - -
- Represents Global Regulatory Affairs (US RA AdPromo) as a
member of cross-functional brand and portfolio team review
committees (RC), providing regulatory input into the review and
approval of US advertising, promotion, disease-state, market
access, and press materials. Submits materials on form FDA 2253
when applicable.
- Provides US RA AdPromo strategic guidance and subject matter
expertise for responsible investigational and marketed products, to
meet both short- and long-term business objectives while mitigating
risk. Consults with senior management and provides input to the
global organization as needed.
- Contributes US RA AdPromo input to the development of optimal
FDA product 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 stakeholders (e.g., Legal, Medical,
Marketing, Communications and Compliance).
- Work collaboratively with medical and scientific personnel on
the development and review of materials related to advertising and
promotion.
- Participate in training of sales and marketing personnel on
promotional, labeling and advertising regulations.
- Participates in the development, monitoring and updating of
standards and processes related to drug, device, and biologics US
AdPromo regulations and guidances.Other Position Responsibilities:
- Work with other RC team members to provide input into
improvement of systems and/or processes.
- Provide teams with insight into changes in the regulatory
environment, including updates on FDA enforcement letters,
meetings, guidance documents, and policies, etc.
- Review current policies/practices and guidelines issued by
Federal regulatory agencies and update management as
needed.Competencies and Capabilities -
- This individual is expected to competently and confidently
represent Regulatory Affairs as a key member of cross-functional RC
teams for assigned, as well as for all verbal and written
communications with OPDP/APLB reviewers
- Significant understanding of the U.S. pharmaceutical
marketplace, especially the rules and regulations related to the
promotion of prescription drugs in the Uniteed States
- The individual will require strong verbal and written
communication skills; strong interpersonal skills; good listening
skills; strong negotiation skills; demonstrated customer focus and
demonstrated ability to facilitate appropriate team decisions. - -
- - - - - -Minimum Requirements:Educational Background:
- Bachelor's degree from an accredited four-year college or
university (Area of specialization: Life Sciences)Job-Related
Experience:
- At least five (5) years of experience involving the direct
implementation of promotional labeling and advertising regulations
in the biotech/pharmaceutical/medical device industry; this must
include extensive experience providing regulatory input and
evaluation as part of a promotional review committee.This position
can be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote
working arrangement can also be considered.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-SG - #LI-GZPDNAt 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, Chelsea , Associate Director, US Advertising and Promotion, Global Regulatory Affairs, Executive , Cambridge, Massachusetts
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