Job title: Regulatory Solutions Consultant
Company: Clarivate
Job description: Job Title: Regulatory Solutions Consultant Department: Professional Services – Life Sciences Reports To: Associate Manager, Regulatory Consulting Services Location: India The Regulatory Solutions Consultant is a member of Life Sciences Consulting Ser
Job Title: Regulatory Solutions Consultant Department: Professional Services – Life Sciences Reports To: Associate Manager, Regulatory Consulting Services Location: India The Regulatory Solutions Consultant is a member of Life Sciences Consulting Services team reporting directly to the Associate 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 Assoc. 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 not a core submission profile, this is a great opportunity to lead several different projects which includes: Regulatory Intelligence, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, and pharmacovigilance projects. We work with companies with portfolios that include both chemical and biologics, as well as Medical Devices. 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. 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 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 Sr. 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. 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 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 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 Teams It is the policy of Clarivate to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, pregnancy, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Clarivate will provide reasonable accommodations for qualified individuals with disabilities.
Expected salary:
Location: Bangalore, Karnataka
Job date: Mon, 05 Sep 2022 22:38:48 GMT
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