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Regulatory Affairs Manager

Company: ProClinical
Location: Warren
Posted on: September 22, 2022

Job Description:

Proclinical is seeking to hire a Regulatory Affairs Manager located in Warren, NJ.Job Responsibilities:

  • Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA).
  • Work on OTC products, develop regulatory label, review claims and copy
  • Recommend and execute regulatory strategies for the portfolio, proactively seeking innovative and rapid path to market.
  • Collaborate with US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS
  • Support end-to-end regulatory compliance of products in remit.
  • Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
  • Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.
  • Maintain high level of knowledge on the science of products within defined portfolio.If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at (+1) 267-846-2026 or j.cerchio@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.#LI-JC8Job Requirements:*Represent USRA on assigned projects, provide guidance on OTC drug regulatory pathways (monograph, NDA).
    ---Work on OTC products, develop regulatory label, review claims and copy
    ---Recommend and execute regulatory strategies for the portfolio, proactively seeking innovative and rapid path to market.
    ---Collaborate with US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS
    ---Support end-to-end regulatory compliance of products in remit.
    ---Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
    ---Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business.
    ---Maintain high level of knowledge on the science of products within defined portfolio.

Keywords: ProClinical, Elizabeth , Regulatory Affairs Manager, Executive , Warren, New Jersey

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