Regulatory Compliance Manager

Randstad Enterprises partners with a well-respected Biotechnology company in RTP to hire amazing talent that convert to becoming a full-time employee. We are currently seeking an amazing talent to jump into the Regulatory Compliance space and add immediate value. Hybrid Role in RTPDurhamMonday - FridayThe Regulatory Compliance Manager will be someone who can establish and govern a regulatory intelligence program for PO&T. Consisting of research, analyzing, interpreting, communicating and acting on publicly available regulatory information to drive comp0liance, 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)Position will be working on:Perform andor 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 the 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 municate the intelligence to relevant groups within PO&T in a timely manner via written communication.Maintain up-to-date general knowledge of regulatory guidance's and regulations to facilitate collection and evaluation of the ongoing regulatory climate.Coordinate reviews of draft legislationguidance ensuring alignment between all affected functions influencing regulations.Experience and Education:Bachelor's Degree (BS) from a four-year college or university with an emphasis in ScienceEngineering; or an equivalent combination of education and experience.Minimum ten (10) years' experience in pharmaceuticalbiotech industry.

Created: 2024-10-27