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.