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Sanofi Group
GRA Global AdPromo Excellence Lead
Career Insights for Regulatory Affairs Specialist
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What they do
A Regulatory Affairs Specialist maintains specialized knowledge of state and federal government regulations that affect an employer. Interprets regulations and implements procedures that bring an employer into compliance with regulations; may audit internal compliance with regulations.
$108,716 / year median in New Jersey
+2% projected growth
Job Description
Morristown, NJ Cambridge, MA Full time
R2866232
- Job title
- : GRA Global AdPromo Excellence Lead +
Location:
Morristown, NJ - Cambridge, MA- _About the job_
- A hybrid role combining support for global promotional material regulatory review (30%) with transversal excellence activities (70%).
- _
About Sanofi:
_- We're an R D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
- _
Main Responsibilities:
_- Global AdPromo Regulatory Review (~30%)
- + Work closely with the assigned global business units (commercial and medical) in the development of promotional / non-promotional materials, their review and prior approval.
- Excellence Support Activities (~70%)
- Innovation & Transformation Support
- + Represent GRA AdPromo in transformation programs and cross-functional initiatives + Support the evaluation and testing of digital tools and Gen AI use cases under guidance from the Excellence Head + Help compile data and observations for system and process reviews
- Stakeholder Coordination
- + Support coordination activities with transversal partners and regional teams + Assist in preparing materials and communications for stakeholder meetings and updates + Advocate for the AdPromo team's strategic value and priorities
- Operational Excellence Support
- + Assist with data collection and documentation for gap analyses of regulatory processes + Support maintenance of KPI reporting and dashboards by gathering and organizing relevant data + Help document best practices, process updates, and SOP revisions under senior guidance
- Training & Capability Building Support
- + Assist in the preparation process documentation for both transversal and regulatory + Help maintain and update global training materials + Conduct upskilling sessions with (regional) regulatory teams on digital initiatives
- Governance & Ways of Working Support
- + Provide administrative and coordination support for GRA AdPromo Governance activities + Assist in team engagement activities such as town halls and workshops
- _About you_
- Education
- + BA/BS degree in Pharmaceutical Sciences, Life Sciences, or related discipline required (other degrees considered with relevant experience)
- Experience
- + 2+ years of experience in the biopharmaceutical industry performing regulatory affairs advertising and promotion review
- Required Skills
- + Good understanding of global codes and standards including ability to review against the EFPIA and IFPMA standards + Interpret complex clinical data (eg, CSRs, medical publications) + Possesses sufficient scientific and clinical knowledge to understand disease states, mechanisms of action, clinical trial design, and statistical concepts relevant to the products being reviewed + Use data and local SmPC to inform compliant messaging + Understand review standards for branded, disease awareness, and medical congress content •Preferred Technical & Soft Skills•+ Experience supporting transversal and/or digital transformation initiatives like Gen AI, Modular Content, Core Claims, and or other MLR programs.
- Language
- + English (fluent required); additional languages beneficial
- _Why choose us?_
- + Bring the miracles of science to life alongside a supportive, future-focused team.
- Pursue
- _progress_
- , discover
- _extraordinary_
- Better is out there.