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Regulatory Affairs Specialist
1 week ago
Philips Iberica SAU Hartford, United StatesJob Title Regulatory Affairs Specialist Job Description Looking at the challenges the world is facing today Philips purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, youll be working towards creating a better and fairer fut ...
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Regulatory Affairs Manager
2 weeks ago
Blueroot Health™ Hartford, United StatesPURPOSE STATEMENT: · This position will be responsible for managing and coordinating implementation of regulatory requirements across all Blueroot Health brands, reflective of both the FDA CFR section 111 and the Company's policies and practices. This coordination includes makin ...
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Regulatory Affairs Specialist
1 day ago
Onsite Personnel LLC Newtown, United StatesJob Description · Job DescriptionOverview: Regulatory Associate:Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA. · Key Duties & Resp ...
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Regulatory Affairs Manager
5 days ago
Blueroot Health™ Connecticut, United StatesPURPOSE STATEMENT: · This position will be responsible for managing and coordinating implementation of regulatory requirements across all Blueroot Health brands, reflective of both the FDA CFR section 111 and the Company's policies and practices. This coordination includes maki ...
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Regulatory Affairs Manager
1 week ago
MicroCare LLC New Britain, United StatesJob Description · Job DescriptionImagine working for a company that knows their employees are the key to its success, a company that provides exceptional results while being environmentally conscious and ahead of the curve in research and development; MicroCare LLC is that compan ...
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Sr. Regulatory Affairs Specialist-CT/AMI
1 week ago
Philips Iberica SAU Hartford, United StatesJob Title Sr. Regulatory Affairs Specialist-CT/AMI Job Description · The Senior RA Specialist will play a critical role in ensuring Philips Computed Tomography (CT) and Advanced Molecular Imaging (AMI) solutions are · safe, reliable, and compliant through · driving global regu ...
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Sr. Regulatory Affairs Specialist-CT/AMI
1 week ago
Philips International Hartford, United StatesSr. Regulatory Affairs Specialist-CT/AMI page is loaded · Sr. Regulatory Affairs Specialist-CT/AMI · Apply · locations · Orange (OH) · Pittsburgh · Rosemont · San Diego · Plymouth · time type · Full time · posted on · Posted 19 Days Ago · job requisition id · 520700 ...
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Senior Regulatory Affairs Specialist
1 week ago
Safeguard Medical Harrisburg, United StatesThe Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products. · This position requires a deep understanding of the regulatory landscape and the ability to navigate complex reg ...
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Senior Regulatory Affairs Specialist
1 week ago
Safeguard Medical Harrisburg, United StatesThe Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products.This position requires a deep understanding of the regulatory landscape and the ability to navigate complex regula ...
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Regulatory Analyst
1 week ago
The Travelers Companies, Inc. Hartford, United StatesWho Are We? · - Taking care of our customers, our communities and each other. That's the Travelers Promise. By honoring this commitment, we have maintained our reputation as one of the best property casualty insurers in the industry for over 160 years. Join us to discover a cultu ...
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Manager, Strategic Project Development
1 week ago
EVERSOURCE Hartford, United States**Our Team** · Eversource is looking for a** Manager, Strategic Project Development **located in **Hartford, CT.** · A key point of success will include building relationships and work collaboratively with all internal departments within the Company including System Planning, Eng ...
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Scientist I, Process Development
1 week ago
Thermo Fisher Scientific Plainville, United StatesScientist I, Process Development (Viral Vector Services) · Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Whether our customer ...
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General Counsel
1 week ago
Quinnipiac University Hamden, United States**Job Number**: 495795 · **Type**: Full-time · **Campus**: Mount Carmel - Hamden, CT · **Categories**: Staff · - Overview: · Quinnipiac University seeks to hire a General Counsel, to work with a dynamic and energetic president and senior management team. The General Counsel will ...
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vp, aetna interoperability
1 week ago
CVS Hartford, CT , USA, United StatesBring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing w Strategy, Health, Regulatory ...
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Sr Clinical Trials Registration Specialist
1 week ago
St. Jude Children's Research Hospital Hartford, United StatesSr Clinical Trial Registration Specialist Manages day-to-day operations and system applications associated with Clinical (CTG) and NCI's Clinical Trial Reporting Program (CTRP) reporting and/or monitoring for all St. Jude Children's Research Hospital trials. Utilizes clinical re ...
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Regulatory Analyst
3 days ago
VetJobs Hartford, United StatesJob Description · ATTENTION MILITARY AFFILIATED JOB SEEKERS · - Our organization works with partner companies to source qualified talent for their open roles. The following position is available to Veterans, Transitioning Military, National Guard and Reserve Members, Military S ...
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Chief Human Resources Officer
1 week ago
Charter Oak Health Center Inc Hartford, United States: · Position Summary: · The Chief Human Resources Officer (CHRO) is responsible for developing and executing the human resource strategy of the organization, specifically in the areas of succession planning, talent management, change management, organization and performance manag ...
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Regulatory Group Leader
1 week ago
KVK Tech Newtown, United StatesJob Description · Job DescriptionDepartment · Regulatory Affairs · Job Title · Group Leader · FLSA Status · Exempt · Reports To · Direct of Regulatory Affairs · 1. Role Purpose: · Primary responsibilities are to manage, prepare and submit regulatory submissions by successfully co ...
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Head Coach
1 week ago
Post University Waterbury, United StatesPost University is seeking a **Head Coach - Women's Ice Hockey **to join our growing team. · **WHY POST?** · Post University has an immediate opening for an exceptional Head Coach - Women's Ice Hockey. Post University is a legendary, dynamic, growth-oriented organization of passi ...
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Eversource Energy Hartford, United StatesThis is a hybrid role with the first three months in the office. · Eversource is looking for a · Senior Program Manager, Strategic Project Development, Transmission · located in · Hartford, CT · or · Westwood, MA · or · Hooksett, NH .You will be responsible for advancing M ...
Lead Consultant, Regulatory Affairs - Hartford, United States - Clarivate Analytics US LLC
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Description
Clarivate is a leading global provider of transformative intelligence.We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare.
Our connected data, deep expertise and intelligence platforms empower life sciences and healthcare companies to deliver safe, effective and commercially successful treatments to patients faster.
Clarivate is home to Cortellis, solutions for real world data, medtech, market access and commercialization and deep consulting expertise.We help companies advance their drug discovery, preclinical proof-of-concept, and regulatory activities.
Clarivate's translational science expertise, skilled teams of regulatory and commercial experts and assets such as the Centre for Medicine Research (CMR) combine to offer a highly reputable source of pharmaceutical industry metrics and insights.
By providing perspective, data and insights across the development spectrum, we complement client teams in generating long term value.Our Regulatory & Clinical Consulting Services team in US is looking for a Lead Consultant.
This position can be performed near any US Clarivate office or fully remote
Responsibilities of this role include:
Business development (30%)
Provides responses to any received RFI and RFPs.
Holding scoping discussions with customers to ensure Clarivate Analytics have a robust understanding of a customer's needs and requirements for any given project.
Working with Consulting services colleagues to provide robust effort estimates for scoped projects.Drafting customer facing materials to support proposals and service request forms.
Build a sustainable pipeline of services offerings and projects by identifying clients, understanding client requirements, and delivering unique solutions to each client ask.
Communicates services offerings of the practice area, in RFP responses, and in support of individual opportunities to sales and to customers.
Develops case studies that describe practice area offerings and ensure those case studies are communicated and accessible.Participates in opportunity development, to architect solutions and support the planning of consulting service projects from inception to contract closing.
Supports proof of concept deliverables to demonstrate technical proof during sales process.Coaching of Presales Solutions Specialists to increase their knowledge of Regulatory Services to support presales discussions
Project Delivery Support (70%)
Become an integral member of the customer facing team of the Life Sciences Consulting Services team.
Act as the primary point of contact for the customer throughout a project's lifecycle to ensure a high quality of service and deliverables.
Act as the project manager for regulatory consulting services to ensure successful and timely delivery of each assigned project.Co-ordinate resources across the R&C Practice and potentially third party vendors to ensure the successful delivery of relevant projects.
Escalates any project risks and delivery issues to the R&C Consulting Director for action and resolution.
Supports and delivers proof of concept solutions to validate the understanding between the proposed solution and customer needs identified during the sales process.
Collaborates with other Life Sciences Consulting Services teams to meet the client needs by employing the Clarivate Analytics suite of databases and Enabling Technology solutions.
Qualifications and Experience:
Master's Degree in life sciences
A minimum of 10 years' experience in Pharmaceutical Regulatory Affairs/Regulatory Intelligence across major markets (Europe, North America, Asia Pacific) in Life Science industry and/or in consulting companies.
Experience in supporting Regulatory services from conception to delivery in a customer facing role, preferably within a consulting service provider.
Knowledge and skills:
Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, technical standards
Expert knowledge of relevant markets from a regulatory/clinical perspective
Excellent customer facing 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 in a demanding and changing environment
Independent worker with excellent time management skills
Travel:
infrequent travel may be required.
Clarivate is an Equal Opportunity Employer Vets/Minorities/Women/Disabled
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Lead Consultant, Regulatory Affairs professionals in Hartford
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Sushma Yammanuru
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Mahesh S
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