The Regulatory Solutions Consultant provides regulatory intelligence to the global pharmaceutical and medical device community and is a member of Life Sciences Consulting Services team; reporting directly to the Manager, Regulatory Consulting Services. The primary purpose of the Regulatory Solutions Consultant role is to support the proposal and delivery of regulatory consulting services globally. This includes working closely with the Manager, Regulatory Services and other team members to ensure that all regulatory projects are delivered on time, within cost and at the highest quality. Additionally, assuring that all contractual obligations are met and customers have a high level of satisfaction whilst engaging with Clarivate Analytics across a project’s lifecycle.
Business development (10%)
Support to any received Requests for Information (RFIs) and Requests for Proposals (RFPs).
Work with professional services colleagues to provide robust effort estimates for scoped projects.
Support the creation of customer facing materials to support commercial discussions such as samples.
Project Delivery Support (90%)
Become an integral member of the delivery team within the Life Sciences Consulting Services group.
Act as a point of contact for the customer throughout a project’s lifecycle.
Act as the project manager for regulatory professional services to ensure successful delivery of each assigned project; which includes coordination and tracking.
Escalate any project risks and delivery issues to the Manager, Regulatory Services for action and resolution.
Support and delivers small pilot projects to validate understanding between the proposed solution and customer needs identified during the sales process.
Support the delivery of non-regulatory consulting services as required and agreed with both their direct and matrix managers.
Deliver on routine projects and single requests.
Qualification and Experience:
Minimum of a Bachelor’s degree in life sciences or Master’s degree in life sciences
Knowledge of pharmaceutical and medical device regulatory affairs / regulatory intelligence across a given geographic area (e.g. Europe or North America) mandatory (familiar with drug pipeline, development / approval / marketing, regulatory concepts).
Experience in supporting regulatory consulting services or projects desirable.
Customer facing or customer service experience desirable.
Experience in 1 or more of the following is highly recommended: PV, CMC, CMC Variations, Clinical, post-market requirements.
Telecommuting is allowed.
Internal Number: RegConsult1
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