Network Partners Group
Principal Regulatory Consultant, Pharmaceuticals
Principal Regulatory Consultant, Pharmaceuticals Due to tremendous growth, Network Partners is looking for a Principal Regulatory Consultant to help continuously develop and enhance our portfolio of industry leading talent within the Pharmaceutical division. 
About us:Network Partners Group is a life sciences professional services provider whose purpose focuses on the support functions necessary to enable Medical Device, Pharmaceutical and Bio-Tech technologies to be marketed in the global marketplace.
The OpportunityNetwork Partners is seeking to hire a Principal Regulatory Consultant to our staff that will work with our client partners remotely to develop regulatory strategy, prepare U.S. and EU submissions and obtain approval to introduce new Class II and Class III medical devices to markets worldwide.

RequirementsAbility to present all information (regulatory and scientific) effectively, both orally and in writing, in a concise, logical, and persuasive manner with excellent written and interpersonal communication skills.Provides guidance on drug and device regulations, regulatory strategy, and pharmaceutical and design controls/design history file deliverables to other combination product regulatory professionals.Set and communicate timelines for the regulatory submissions and for the delivery of supporting documentation. Ability to work with all functional areas to obtain needed information on time.Anticipates the impact of potential team decisions on the regulatory strategy, timelines, project goals, and other programs and influence the team as needed.Reviews scientific information to ensure the data is complete, sound, logical, and supports the program goals.Partners with authors to ensure supporting information is clearly and logically written, in order to ensure it is submission ready.Interact and effectively negotiate with regulatory authoritiesMaintains awareness of applicable regulations and guidances and informs project teams of new information, along with its possible impact to the project, as appropriate.
Qualifications10-15 years of experience in regulatory affairs, research, development or related area with experience working with RA.Significant experience in both pharmaceutical and medical device regulatory affairs required.Previous experience with combination product regulatory strategy and/or execution is strongly preferred
United States