Regulatory Solutions Consultant
Clarivate Analytics
Hyderabad
6d ago
source : Shine

The Regulatory Solutions Consultant is a member of Life Sciences Consulting Services team; reporting directly to the Sr. Regulatory Solutions Consultant, Regulatory 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 Sr. Regulatory Solutions Consultant, 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 Consulting 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 Consulting services to ensure successful delivery of each assigned project; which includes coordination and tracking.
  • Escalate any project risks and delivery issues to the Sr. Regulatory Solutions Consultant, 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 / pharmacovigilance / 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.
  • Knowledge and Skills :

  • Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, security standards
  • Expert knowledge of relevant markets
  • Excellent customer service skills
  • Strong problem management, troubleshooting and analytical skills
  • Demonstrated ability to work with and manage virtual teams to successfully deliver projects
  • Demonstrated ability to learn and understand internal systems and processes
  • Able to work well under pressure in a demanding environment
  • Independent worker with excellent time management and escalation skills
  • Experience with remote access tools and methods e.g. WebEx
  • Fluent in English is essential
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