The Regulatory Solutions Consultant position will involve data monitoring, data authoring, content development, maintenance & operations related to regulatory consulting projects. Individuals would get exposure to Clarivate-owned Life sciences databases and external data sources. The team is highly skilled, close-knit, and works towards a common goal of delivering quality projects to our global clients in life sciences industry.

We are looking for a Regulatory Solutions Consultant to join our Clinical and Regulatory Team in Hyderabad or Bangalore. This is an amazing opportunity to work on regulatory consulting projects. The team consists of six colleagues and is reporting to the Manager. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials, marketing authorization applications (MAA), chemistry manufacturing and controls (CMC), CMC variations, pharmacovigilance projects, and regulatory strategy, among others, and we would love to speak with you if you have any of the skills or expertise in the regulatory affairs and consulting domain.

About You – experience, education, skills, and accomplishments

• Bachelor’s or master’s degree in pharmaceutical sciences
• Atleast 5 years of relevant work experience in regulatory affairs or in supporting regulatory professional services/ Consulting projects.
• Relevant experience in clinical trial data optimization, clinical data management, MAA submissions
• Regulatory Intelligence – Pharmacovigilance, Clinical Trial, New and post approval registrations, etc.
• Customer facing or customer service experience desirable.
• Demonstrated ability to learn on new domains, understand internal systems & processes and perform at the same time.

It would be great if you also had . . .

• Exposure to regulatory consulting
• Master's degree in regulatory affairs
• A flexible and collaborative approach to work
• Ability to prioritize effectively and adopt a systematic approach to tasks

What will you be doing in this role?

Project Delivery Support (80%)

• 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 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.
• Deliver on routine projects, new development and one-off requests.

Business development (20%)

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

Projects you will be working on

Various regulatory consulting projects such as data monitoring, content authoring, regulatory landscape, precedence analysis, newsletters, custom dashboards, guidance interpretation, gap analysis. The team works for global clients in multiple domains of clinical and drug regulatory space for multiple product types.

About the Team

The Clinical and Regulatory Consulting Team works towards adding value to data from different sources and providing professional regulatory services to our global clients. The team works with internal database like Cortellis intelligence, etc. and with the external local consultants/ partners. The team here demonstrates good networking skills, establish rapport with the client and internal/external stakeholders.

Hours of Work

The team is based out of India (Hyderabad or Bangalore) with Hybrid presence at office (2 to 3 days per week work from office) and works from 9 AM to 6 PM. The position is permanent and full-time.

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.