Hardik Panchal
Associate Director, Advertising Promotion Regulatory Affairs Vaccines Biologics @Sanofi
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WORK HISTORY
Associate Director, Advertising Promotion Regulatory Affairs Vaccines Biologics @Sanofi
Advertising & Promotion Review & Medical Material Review – o Support US GRA AdPromo in the review & approval of ad-promo pieces, concept strategy & external communications in compliance with the FDA regulations/guidance & internal procedures. o Represent GRA (US AdPromo) as a member of cross-functional brand & portfolio team review committees (RC), providing regulatory input into the review and approval of advertising, promotion, disease-state, medical, market access, & press materials related to Sanofi vaccine portfolio including influenza (flu), non-influenza, development, & joint venture projects. o Provides US AdPromo strategies & opinions for investigational & marketing products to mitigate risk, provide advice & give risk/benefit analysis to meet both short- and long-term growth targets. Consult with senior management & provide input to the Global organization when necessary. o Providing regulatory assessment of Real-World Evidence (RWE) data to be used in AdPromo materials by assuring they are consistent with FDA-required Labeling (CFL) guidance. o Serve as Primary Liaison with the Advertising and Promotional Labeling Branch (APLB) of the FDA & effectively manage relationships with FDA contacts; establish & maintain strong collaborative relationships with Regulatory & other R&D colleagues, as well as with cross functional team members to successfully facilitate the accomplishment of work goals. o Submit materials on form FDA 2253 when applicable. o Collaborate with internal team on AdPromo challenges for resolution & participate in the development, monitoring & updating of standards & processes related to AdPromo regulations & guidance’s- Labeling Working Group (LWG) – o Actively participate in LWG & contribute AdPromo expertise to the development of optimal FDA labeling for New Drug Applications and/or Biologics License Applications. o Managing formatted output process for all the labeling updates related to Sanofi vaccine portfolio.
EDUCATION
L M College of Pharmacy
Bachelor's degree, Pharmacy
Stevens Institute of Technology
Master of Science (MS), Pharmaceutical Sciences
SKILLS
ABOUT HARDIK PANCHAL
SUMMARY: Highly qualified pharmaceutical professional with over 4 years of experience in…
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