Job Description

Job Title: Regulatory Solutions Consultant

Department: Clinical and Regulatory Consulting - Life Sciences

Reports To: Manager, Regulatory Consulting Services

Location: India

The Regulatory Solutions Consultant 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.

This is a great opportunity to increase your background and lead several different Regulatory Intelligence projects related with clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, and regulatory strategy, among others. We work with companies with portfolios that include both chemical and biologics, as well as Medical Devices and Invitro Diagnostics. With this role you will support global clients on their challenges when operating globally, providing regulatory intelligence support and helping them to be more efficient and strategic.

The role will sometimes require you to work individually or as part of a team with knowledge sharing or as team player.

Project Delivery Support (90%)

• Become an integral member of the delivery team within the Life Sciences Consulting group.

• Act as a point of contact for the customer throughout a project\xe2\x80\x99s 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 professional services as required and agreed with both their direct and matrix managers.

• Deliver on routine projects and single requests.

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.

Qualification and Experience:

• Minimum of a Bachelor\xe2\x80\x99s degree in life sciences or Master\xe2\x80\x99s 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 professional 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

• Relevant experience in clinical trial data optimization, clinical data management, MAA submissions

• Regulatory Intelligence \xe2\x80\x93 Pharmacovigilance, Clinical Trial, New and post approval registrations, etc.

• 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. MS Team

At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

Clarivate