Regulatory Compliance Specialist

3 weeks ago


Durham, North Carolina, United States Randstad Enterprise Full time

Randstad Enterprises partners with a well-respected Biotechnology company in RTP to hire talented professionals who can excel in the Regulatory Compliance space and add immediate value.

Hybrid Role in RTP/Durham

Monday - Friday

The Regulatory Compliance Manager will be responsible for establishing and governing a regulatory intelligence program for PO&T. This program will consist of research, analysis, interpretation, communication, and action on publicly available regulatory information to drive compliance, shape future regulations, and outline risks and opportunities to GxP operations. (GxP oversight related to US, EU, JP, and ROW regulations including GMP, GLP, GDP, and PV)

Key Responsibilities:

  • Perform and/or oversee surveillance of publicly available regulatory information from global regulatory agencies and industry forums.
  • Develop, implement, and maintain an effective regulatory information database to summarize and analyze new or changing regulatory information and its potential impact.
  • Track information and document generated responses plans, within the database, to ensure appropriate cross-functional collaboration and monitor response plans to closure.
  • Identify and assess potential impact of regulatory information on products, programs, or regulatory practices.
  • Communicate the intelligence to relevant groups within PO&T in a timely manner via written communication.
  • Maintain up-to-date general knowledge of regulatory guidance and regulations to facilitate collection and evaluation of the ongoing regulatory climate.
  • Coordinate reviews of draft legislation/guidance ensuring alignment between all affected functions influencing regulations.

Requirements:

  • Bachelor's Degree (BS) from a four-year college or university with an emphasis in Science/Engineering; or an equivalent combination of education and experience.
  • Minimum ten (10) years' experience in pharmaceutical/biotech industry.


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