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Regulatory Affairs Specialist Team Lead

Remote Bridgewater, NJ

Work Schedule: 1st shift 8am-5pm Mon-Fri

Location: Bridgewater, NJ - 100% remote

Contract Length: 5 Months 27 days possibility to extend


Sanofi's contingent workforce program, FLEXT Direct, is seeking a Regulatory Affairs Specialist Project Lead for an 5 month 27 day contract.


Description:

This role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development.


Additionally, this role leads the development of a global HA (Health Authority) interaction plan and strategy in collaboration with GRT (Global Regulatory Team) and is accountable for the communication of the key outcomes to senior management.


Top 3 Must Have:

  • Leadership capabilities and ability to work with cross-functional team • Knowing when to escalate concerns
  • Regulatory Experience, 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development Top


Nice Skills:

  • Advanced Degree
  • Filed marketing application (strong plus before)


Experience:

At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development.


Education 

BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.

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